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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01301625




Registration number
NCT01301625
Ethics application status
Date submitted
4/02/2011
Date registered
23/02/2011
Date last updated
7/11/2018

Titles & IDs
Public title
MitraClip System in Australia and New Zealand
Scientific title
A Prospective Single Arm Clinical Trial Evaluating the MitraClip System in Australia and New Zealand
Secondary ID [1] 0 0
Protocol #M10-001
Universal Trial Number (UTN)
Trial acronym
MitraClipANZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Regurgitation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - MitraClip Implant

MitraClip Implant - Eligible patients undergoing a MitraClip procedure in Australia and New Zealand


Treatment: Devices: MitraClip Implant
Percutaneous mitral valve repair using MitraClip implant.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)
Timepoint [3] 0 0
6 months
Primary outcome [4] 0 0
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)
Timepoint [4] 0 0
12 months
Secondary outcome [1] 0 0
Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted
Timepoint [1] 0 0
Day 0 (On the day of procedure)
Secondary outcome [2] 0 0
Number of Participants With Acute Procedural Success Rate
Timepoint [2] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [3] 0 0
Procedure Time
Timepoint [3] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [4] 0 0
Device Time
Timepoint [4] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [5] 0 0
Fluoroscopy Duration
Timepoint [5] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [6] 0 0
Total Contrast Volume
Timepoint [6] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [7] 0 0
Left Ventricle End Diastolic Volume (LVEDV)
Timepoint [7] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [8] 0 0
Left Ventricle End Diastolic Volume (LVEDV)
Timepoint [8] 0 0
At Baseline and 30 Days
Secondary outcome [9] 0 0
Left Ventricle End Diastolic Volume (LVEDV)
Timepoint [9] 0 0
At Baseline and 12 months
Secondary outcome [10] 0 0
Left Ventricular End Systolic Volume (LVESV)
Timepoint [10] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [11] 0 0
Left Ventricular End Systolic Volume (LVESV)
Timepoint [11] 0 0
At Baseline and 30 Days
Secondary outcome [12] 0 0
Left Ventricular End Systolic Volume (LVESV)
Timepoint [12] 0 0
At Baseline and 12 months
Secondary outcome [13] 0 0
Left Ventricular Ejection Fraction (LVEF)
Timepoint [13] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [14] 0 0
Left Ventricular Ejection Fraction (LVEF)
Timepoint [14] 0 0
At Baseline and 30 Days
Secondary outcome [15] 0 0
Left Ventricular Ejection Fraction (LVEF)
Timepoint [15] 0 0
At Baseline and 12 months
Secondary outcome [16] 0 0
Number of Participants With MR Severity
Timepoint [16] 0 0
Baseline
Secondary outcome [17] 0 0
Number of Participants With MR Severity
Timepoint [17] 0 0
At discharge (=7 days of index procedure)
Secondary outcome [18] 0 0
Number of Participants With MR Severity
Timepoint [18] 0 0
30 days
Secondary outcome [19] 0 0
Number of Participants With MR Severity
Timepoint [19] 0 0
6 months
Secondary outcome [20] 0 0
Number of Participants With MR Severity
Timepoint [20] 0 0
12 months
Secondary outcome [21] 0 0
Left Ventricular Internal Diameter End Diastole (LVIDd)
Timepoint [21] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [22] 0 0
Left Ventricular Internal Diameter End Diastole (LVIDd)
Timepoint [22] 0 0
At Baseline and 30 Days
Secondary outcome [23] 0 0
Left Ventricular Internal Diameter End Diastole (LVIDd)
Timepoint [23] 0 0
At Baseline and 12 Months
Secondary outcome [24] 0 0
Left Ventricular Internal Diameter End Systole (LVIDs)
Timepoint [24] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [25] 0 0
Left Ventricular Internal Diameter End Systole (LVIDs)
Timepoint [25] 0 0
At Baseline and 30 Days
Secondary outcome [26] 0 0
Left Ventricular Internal Diameter End Systole (LVIDs)
Timepoint [26] 0 0
At Baseline and 12 Months
Secondary outcome [27] 0 0
Regurgitant Volume
Timepoint [27] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [28] 0 0
Regurgitant Volume
Timepoint [28] 0 0
At Baseline and 30 Days
Secondary outcome [29] 0 0
Regurgitant Volume
Timepoint [29] 0 0
At Baseline and 12 Months
Secondary outcome [30] 0 0
Regurgitant Fraction
Timepoint [30] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [31] 0 0
Regurgitant Fraction
Timepoint [31] 0 0
At Baseline and 30 Days
Secondary outcome [32] 0 0
Regurgitant Fraction
Timepoint [32] 0 0
At Baseline and 12 Months
Secondary outcome [33] 0 0
Mitral Valve Area (MVA) by Pressure Half-time (PHT)
Timepoint [33] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [34] 0 0
Mitral Valve Area (MVA) by Pressure Half-time (PHT)
Timepoint [34] 0 0
At Baseline and 30 Days
Secondary outcome [35] 0 0
Mitral Valve Area (MVA) by Pressure Half-time (PHT)
Timepoint [35] 0 0
At Baseline and 12 Months
Secondary outcome [36] 0 0
Mitral Valve Mean Gradient
Timepoint [36] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [37] 0 0
Mitral Valve Mean Gradient
Timepoint [37] 0 0
At Baseline and 30 Days
Secondary outcome [38] 0 0
Mitral Valve Mean Gradient
Timepoint [38] 0 0
At Baseline and 12 Months
Secondary outcome [39] 0 0
Left Atrial Volume
Timepoint [39] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [40] 0 0
Left Atrial Volume
Timepoint [40] 0 0
At Baseline and 30 Days
Secondary outcome [41] 0 0
Left Atrial Volume
Timepoint [41] 0 0
At Baseline and 12 Months
Secondary outcome [42] 0 0
Six Minute Walking Distance
Timepoint [42] 0 0
Baseline
Secondary outcome [43] 0 0
Six Minute Walking Distance
Timepoint [43] 0 0
30 days
Secondary outcome [44] 0 0
Six Minute Walking Distance
Timepoint [44] 0 0
6 months
Secondary outcome [45] 0 0
Six Minute Walking Distance
Timepoint [45] 0 0
12 months
Secondary outcome [46] 0 0
Percentage of Participants With New York Heart Association (NYHA) Class
Timepoint [46] 0 0
Baseline
Secondary outcome [47] 0 0
Percentage of Participants With New York Heart Association (NYHA) Class
Timepoint [47] 0 0
30 days
Secondary outcome [48] 0 0
Percentage of Participants With New York Heart Association (NYHA) Class
Timepoint [48] 0 0
6 months
Secondary outcome [49] 0 0
Percentage of Participants With New York Heart Association (NYHA) Class
Timepoint [49] 0 0
12 months
Secondary outcome [50] 0 0
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 30 Days
Timepoint [50] 0 0
30 days
Secondary outcome [51] 0 0
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 6 Months
Timepoint [51] 0 0
6 months
Secondary outcome [52] 0 0
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 12 Months
Timepoint [52] 0 0
12 months
Secondary outcome [53] 0 0
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)
Timepoint [53] 0 0
Baseline
Secondary outcome [54] 0 0
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)
Timepoint [54] 0 0
30 days
Secondary outcome [55] 0 0
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)
Timepoint [55] 0 0
6 months
Secondary outcome [56] 0 0
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)
Timepoint [56] 0 0
12 months
Secondary outcome [57] 0 0
Number of Participants With Mitral Valve Surgery
Timepoint [57] 0 0
30 days of Post-MitraClip Procedure
Secondary outcome [58] 0 0
Number of Participants With Second Intervention to Place an Additional MitraClip Device
Timepoint [58] 0 0
Through 12 months
Secondary outcome [59] 0 0
Rate of Patients Rehospitalized
Timepoint [59] 0 0
30 days
Secondary outcome [60] 0 0
Duration of Rehospitalization
Timepoint [60] 0 0
30 days
Secondary outcome [61] 0 0
Number of Participants at Discharge Facility
Timepoint [61] 0 0
< or = 12 days
Secondary outcome [62] 0 0
Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration
Timepoint [62] 0 0
Post index procedure within 30 days
Secondary outcome [63] 0 0
Post-procedure Hospital Stay
Timepoint [63] 0 0
Post index procedure within 30 days

Eligibility
Key inclusion criteria
* Age 18 years or older.
* MR = 3+ .
* Transseptal catheterization and femoral vein access feasible.
* Placement of the MitraClip device on mitral leaflets feasible.
* Mitral valve orifice area = 4.0 cm2.
* Written informed consent obtained.
* The patient agrees to return for follow-up visits.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Need for emergency surgery, other cardiac surgery.
* Coronary artery disease (CAD), atrial fibrillation (AF), other valve disease.
* Prior mitral valve repair surgery, mechanical prosthetic valve, or ventricular assist device (VAD).
* Active endocarditis or rheumatic heart disease; leaflets degenerated from endocarditis or rheumatic disease.
* Transesophageal echocardiography (TEE) contraindicated.
* Known hypersensitivity or contraindication to trial or procedure medications which cannot be managed medically.
* Currently participating in investigational drug trial or another device trial that has not yet completed the primary endpoint or that interferes with the MitraClip System ANZ Clinical Trial.
* Pregnant or planning pregnancy within next 12 months.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Macquarie University Hosptial - North Ryde
Recruitment hospital [3] 0 0
North Shore Private Hospital - St Leonards
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2109 - North Ryde
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Abbott
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the MitraClip System Australia and New Zealand (ANZ) Clinical Trial is to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the MitraClip System in the continuum of therapies for treating MR. Specifically, the following clinical and economic data will be collected: New York Heart Association (NYHA) Functional Class, Six-Minute Walk Test (6MWT) distance, quality of life (QOL) information, echocardiographic measures of left ventricular size and function, and data associated with the index hospitalization, rehospitalizations, concomitant medications and discharge facility to support the MitraClip System economic analysis.
Trial website
https://clinicaltrials.gov/study/NCT01301625
Trial related presentations / publications
Mauri L, Garg P, Massaro JM, Foster E, Glower D, Mehoudar P, Powell F, Komtebedde J, McDermott E, Feldman T. The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation. Am Heart J. 2010 Jul;160(1):23-9. doi: 10.1016/j.ahj.2010.04.009.
Whitlow PL, Feldman T, Pedersen WR, Lim DS, Kipperman R, Smalling R, Bajwa T, Herrmann HC, Lasala J, Maddux JT, Tuzcu M, Kapadia S, Trento A, Siegel RJ, Foster E, Glower D, Mauri L, Kar S; EVEREST II Investigators. Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol. 2012 Jan 10;59(2):130-9. doi: 10.1016/j.jacc.2011.08.067.
Tamburino C, Ussia GP, Maisano F, Capodanno D, La Canna G, Scandura S, Colombo A, Giacomini A, Michev I, Mangiafico S, Cammalleri V, Barbanti M, Alfieri O. Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting. Eur Heart J. 2010 Jun;31(11):1382-9. doi: 10.1093/eurheartj/ehq051. Epub 2010 Mar 18.
Ussia GP, Barbanti M, Tamburino C. Feasibility of percutaneous transcatheter mitral valve repair with the MitraClip system using conscious sedation. Catheter Cardiovasc Interv. 2010 Jun 1;75(7):1137-40. doi: 10.1002/ccd.22415.
Jonsson A, Settergren M. MitraClip catheter-based mitral valve repair system. Expert Rev Med Devices. 2010 Jul;7(4):439-47. doi: 10.1586/erd.10.23.
Argenziano M, Skipper E, Heimansohn D, Letsou GV, Woo YJ, Kron I, Alexander J, Cleveland J, Kong B, Davidson M, Vassiliades T, Krieger K, Sako E, Tibi P, Galloway A, Foster E, Feldman T, Glower D; EVEREST Investigators. Surgical revision after percutaneous mitral repair with the MitraClip device. Ann Thorac Surg. 2010 Jan;89(1):72-80; discussion p 80. doi: 10.1016/j.athoracsur.2009.08.063.
Geidel S, Ostermeyer J, Lass M, Schmoeckel M. Complex surgical valve repair after failed percutaneous mitral intervention using the MitraClip device. Ann Thorac Surg. 2010 Jul;90(1):277-9. doi: 10.1016/j.athoracsur.2009.12.048.
Kalarus Z, Kukulski T, Lekston A, Streb W, Sikora J, Nadziakiewicz P, Gasior M, Polonski L, Zembala M. [Methodology and safety of transvascular reduction of severe ischaemic mitral insufficiency with MitraClip in high-surgical-risk patients - first three cases in Poland]. Kardiol Pol. 2010 Jun;68(6):729-35. Polish.
Lim DS, Kunjummen BJ, Smalling R. Mitral valve repair with the MitraClip device after prior surgical mitral annuloplasty. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):455-9. doi: 10.1002/ccd.22547.
Ciobanu A, Bennett S, Azam M, Clark A, Vinereanu D. Incremental value of three-dimensional transoesophageal echocardiography for guiding double percutaneous MitraClip (R) implantation in a 'no option' patient. Eur J Echocardiogr. 2011 Feb;12(2):E11. doi: 10.1093/ejechocard/jeq118. Epub 2010 Sep 27.
Tamburino C, Imme S, Barbanti M, Mule M, Pistritto AM, Aruta P, Cammalleri V, Scarabelli M, Mangiafico S, Scandura S, Ussia GP. Reduction of mitral valve regurgitation with Mitraclip(R) percutaneous system. Minerva Cardioangiol. 2010 Oct;58(5):589-98.
Borgia F, Di Mario C, Franzen O. Adenosine-induced asystole to facilitate MitraClip placement in a patient with adverse mitral valve morphology. Heart. 2011 May;97(10):864. doi: 10.1136/hrt.2010.208132. Epub 2010 Oct 29. No abstract available.
Luk A, Butany J, Ahn E, Fann JI, St Goar F, Thornton T, McDermott L, Madayag C, Komtebedde J. Mitral repair with the Evalve MitraClip device: histopathologic findings in the porcine model. Cardiovasc Pathol. 2009 Sep-Oct;18(5):279-85. doi: 10.1016/j.carpath.2008.07.001. Epub 2008 Aug 13.
Herrmann HC, Kar S, Siegel R, Fail P, Loghin C, Lim S, Hahn R, Rogers JH, Bommer WJ, Wang A, Berke A, Lerakis S, Kramer P, Wong SC, Foster E, Glower D, Feldman T; EVEREST Investigators. Effect of percutaneous mitral repair with the MitraClip device on mitral valve area and gradient. EuroIntervention. 2009 Jan;4(4):437-42. doi: 10.4244/eijv4i4a76.
Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D; EVEREST Investigators. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol. 2009 Aug 18;54(8):686-94. doi: 10.1016/j.jacc.2009.03.077.
Rogers JH, Yeo KK, Carroll JD, Cleveland J, Reece TB, Gillinov AM, Rodriguez L, Whitlow P, Woo YJ, Herrmann HC, Young JN. Late surgical mitral valve repair after percutaneous repair with the MitraClip system. J Card Surg. 2009 Nov-Dec;24(6):677-81. doi: 10.1111/j.1540-8191.2009.00901.x. Epub 2009 Jul 24.
Silvestry FE, Rodriguez LL, Herrmann HC, Rohatgi S, Weiss SJ, Stewart WJ, Homma S, Goyal N, Pulerwitz T, Zunamon A, Hamilton A, Merlino J, Martin R, Krabill K, Block PC, Whitlow P, Tuzcu EM, Kapadia S, Gray WA, Reisman M, Wasserman H, Schwartz A, Foster E, Feldman T, Wiegers SE. Echocardiographic guidance and assessment of percutaneous repair for mitral regurgitation with the Evalve MitraClip: lessons learned from EVEREST I. J Am Soc Echocardiogr. 2007 Oct;20(10):1131-40. doi: 10.1016/j.echo.2007.02.003. Epub 2007 Jun 13.
Herrmann HC, Rohatgi S, Wasserman HS, Block P, Gray W, Hamilton A, Zunamon A, Homma S, Di Tullio MR, Kraybill K, Merlino J, Martin R, Rodriguez L, Stewart WJ, Whitlow P, Wiegers SE, Silvestry FE, Foster E, Feldman T. Mitral valve hemodynamic effects of percutaneous edge-to-edge repair with the MitraClip device for mitral regurgitation. Catheter Cardiovasc Interv. 2006 Dec;68(6):821-8. doi: 10.1002/ccd.20917.
Feldman T, Foster E, Glower DD, Kar S, Rinaldi MJ, Fail PS, Smalling RW, Siegel R, Rose GA, Engeron E, Loghin C, Trento A, Skipper ER, Fudge T, Letsou GV, Massaro JM, Mauri L; EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011 Apr 14;364(15):1395-406. doi: 10.1056/NEJMoa1009355. Epub 2011 Apr 4. Erratum In: N Engl J Med. 2011 Jul 14;365(2):189. Glower, Donald G [corrected to Glower, Donald D].
Ladich E, Michaels MB, Jones RM, McDermott E, Coleman L, Komtebedde J, Glower D, Argenziano M, Feldman T, Nakano M, Virmani R; Endovascular Valve Edge-to-Edge Repair Study (EVEREST) Investigators. Pathological healing response of explanted MitraClip devices. Circulation. 2011 Apr 5;123(13):1418-27. doi: 10.1161/CIRCULATIONAHA.110.978130. Epub 2011 Mar 21.
Siegel RJ, Biner S, Rafique AM, Rinaldi M, Lim S, Fail P, Hermiller J, Smalling R, Whitlow PL, Herrmann HC, Foster E, Feldman T, Glower D, Kar S; EVEREST Investigators. The acute hemodynamic effects of MitraClip therapy. J Am Coll Cardiol. 2011 Apr 19;57(16):1658-65. doi: 10.1016/j.jacc.2010.11.043.
Grayburn PA, Roberts BJ, Aston S, Anwar A, Hebeler RF Jr, Brown DL, Mack MJ. Mechanism and severity of mitral regurgitation by transesophageal echocardiography in patients referred for percutaneous valve repair. Am J Cardiol. 2011 Sep 15;108(6):882-7. doi: 10.1016/j.amjcard.2011.05.013. Epub 2011 Jul 7.
Nor Aripin KN, Sammons HM, Choonara I. Published pediatric randomized drug trials in developing countries, 1996-2002. Paediatr Drugs. 2010 Apr 1;12(2):99-103. doi: 10.2165/11316260-000000000-00000.
Auricchio A, Schillinger W, Meyer S, Maisano F, Hoffmann R, Ussia GP, Pedrazzini GB, van der Heyden J, Fratini S, Klersy C, Komtebedde J, Franzen O; PERMIT-CARE Investigators. Correction of mitral regurgitation in nonresponders to cardiac resynchronization therapy by MitraClip improves symptoms and promotes reverse remodeling. J Am Coll Cardiol. 2011 Nov 15;58(21):2183-9. doi: 10.1016/j.jacc.2011.06.061.
Conradi L, Treede H, Franzen O, Seiffert M, Baldus S, Schirmer J, Meinertz T, Reichenspurner H. Impact of MitraClip therapy on secondary mitral valve surgery in patients at high surgical risk. Eur J Cardiothorac Surg. 2011 Dec;40(6):1521-6. doi: 10.1016/j.ejcts.2011.03.007. Epub 2011 Apr 15.
Divchev D, Kische S, Paranskaya L, Schneider H, Rehders T, Ortak J, Akin I, Turan G, Turan CH, Steinhoff G, Noldge-Schomburg G, Nienaber CA, Ince H. In-hospital outcome of patients with severe mitral valve regurgitation classified as inoperable and treated with the MitraClip(R) device. J Interv Cardiol. 2012 Apr;25(2):180-9. doi: 10.1111/j.1540-8183.2011.00688.x. Epub 2011 Dec 21.
Franzen O, van der Heyden J, Baldus S, Schluter M, Schillinger W, Butter C, Hoffmann R, Corti R, Pedrazzini G, Swaans MJ, Neuss M, Rudolph V, Surder D, Grunenfelder J, Eulenburg C, Reichenspurner H, Meinertz T, Auricchio A. MitraClip(R) therapy in patients with end-stage systolic heart failure. Eur J Heart Fail. 2011 May;13(5):569-76. doi: 10.1093/eurjhf/hfr029. Epub 2011 Apr 6.
Gaemperli O, Moccetti M, Surder D, Biaggi P, Hurlimann D, Kretschmar O, Buehler I, Bettex D, Felix C, Luscher TF, Falk V, Grunenfelder J, Corti R. Acute haemodynamic changes after percutaneous mitral valve repair: relation to mid-term outcomes. Heart. 2012 Jan;98(2):126-32. doi: 10.1136/heartjnl-2011-300705. Epub 2011 Oct 7.
Pleger ST, Mereles D, Schulz-Schonhagen M, Krumsdorf U, Chorianopoulos E, Rottbauer W, Katus HA, Bekeredjian R. Acute safety and 30-day outcome after percutaneous edge-to-edge repair of mitral regurgitation in very high-risk patients. Am J Cardiol. 2011 Nov 15;108(10):1478-82. doi: 10.1016/j.amjcard.2011.06.069. Epub 2011 Sep 3.
Rudolph V, Knap M, Franzen O, Schluter M, de Vries T, Conradi L, Schirmer J, Treede H, Wegscheider K, Costard-Jackle A, Meinertz T, Reichenspurner H, Baldus S. Echocardiographic and clinical outcomes of MitraClip therapy in patients not amenable to surgery. J Am Coll Cardiol. 2011 Nov 15;58(21):2190-5. doi: 10.1016/j.jacc.2011.07.047.
Schillinger W, Athanasiou T, Weicken N, Berg L, Tichelbacker T, Puls M, Hunlich M, Wachter R, Helms HJ, Seipelt R, Schondube FA, Hasenfuss G. Impact of the learning curve on outcomes after percutaneous mitral valve repair with MitraClip and lessons learned after the first 75 consecutive patients. Eur J Heart Fail. 2011 Dec;13(12):1331-9. doi: 10.1093/eurjhf/hfr141. Epub 2011 Oct 24. Erratum In: Eur J Heart Fail. 2012 Jun;14(6):679.
Treede H, Schirmer J, Rudolph V, Franzen O, Knap M, Schluter M, Conradi L, Seiffert M, Koschyk D, Meinertz T, Baldus S, Reichenspurner H. A heart team's perspective on interventional mitral valve repair: percutaneous clip implantation as an important adjunct to a surgical mitral valve program for treatment of high-risk patients. J Thorac Cardiovasc Surg. 2012 Jan;143(1):78-84. doi: 10.1016/j.jtcvs.2011.09.033. Epub 2011 Oct 27.
Ussia GP, Cammalleri V, Sarkar K, Scandura S, Imme S, Pistritto AM, Caggegi A, Chiaranda M, Mangiafico S, Barbanti M, Scarabelli M, Mule M, Aruta P, Tamburino C. Quality of life following percutaneous mitral valve repair with the MitraClip System. Int J Cardiol. 2012 Mar 8;155(2):194-200. doi: 10.1016/j.ijcard.2011.08.853. Epub 2011 Sep 28.
Chan PH, Di Mario C, Franzen O. Dissociation between anatomical and functional results after MitraClip implantation. Int J Cardiol. 2012 Mar 8;155(2):175-6. doi: 10.1016/j.ijcard.2011.10.047. Epub 2011 Nov 9. No abstract available.
Rogers JH, Bolling SF. Editorial comment: Surgery after MitraClip therapy: you can't win them all. Eur J Cardiothorac Surg. 2011 Dec;40(6):1526-8. doi: 10.1016/j.ejcts.2011.04.024. Epub 2011 Jun 12. No abstract available.
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Public notes

Contacts
Principal investigator
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David Muller, MD
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St Vincent's Hospital - Sydney, Australia
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Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01301625