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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02329496

Registration number

NCT02329496

Ethics application status

Date submitted

19/11/2014

Date registered

31/12/2014

Date last updated

24/05/2018

Titles & IDs

Public title

REPRISE Next Generation Delivery System

Scientific title

REPRISE NGDS: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotuS™ ValvE With the Next Generation Delivery System

Secondary ID [1]

S2332

Universal Trial Number (UTN)

Trial acronym

NGDS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Aortic Stenosis

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Devices - Lotus Valve and LOTUS Edge Valve System

Experimental: Lotus Valve and LOTUS Edge Valve System - Transcatheter aortic valve replacement (TAVR) with Lotus Valve System with the Next Generation Delivery System and LOTUS Edge Valve System

Treatment: Devices: Lotus Valve and LOTUS Edge Valve System
Transcatheter aortic valve replacement (TAVR) with the Lotus Valve System with the Next Generation Delivery System and LOTUS Edge Valve System, with either the Lotus Introducer or iSleeve Introducer Sets

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Technical Success

Timepoint [1]

Immediately post-procedure (patient discharged from operative room)

Secondary outcome [1]

Successful repositioning of the study valve if repositioning is attempted

Timepoint [1]

Immediately post-procedure (patient discharged from operative room)

Secondary outcome [2]

Successful retrieval of the study valve if retrieval is attempted

Timepoint [2]

Immediately post-procedure (patient discharged from operative room)

Secondary outcome [3]

Severe or moderate paravalvular aortic regurgitation as measured by echocardiography and assessed by an independent core laboratory

Timepoint [3]

At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [4]

Mild, trace/trivial, or no paravalvular aortic regurgitation as measured by echocardiography and assessed by an independent core laboratory

Timepoint [4]

At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [5]

Mean aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory

Timepoint [5]

At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [6]

Effective orifice area as measured by echocardiography and assessed by an independent core laboratory

Timepoint [6]

At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [7]

Peak aortic valve pressure gradient as measured by echocardiography and assessed by an independent core laboratory

Timepoint [7]

At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [8]

Peak aortic velocity as measured by echocardiography and assessed by an independent core laboratory

Timepoint [8]

At discharge from hospital or at 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [9]

Mortality: all-cause, cardiovascular, and non-cardiovascular

Timepoint [9]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [10]

Stroke: disabling and non-disabling

Timepoint [10]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [11]

Myocardial infarction (MI): periprocedural (=72 hours post index procedure) and spontaneous (>72 hours post index procedure)

Timepoint [11]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [12]

Bleeding: life-threatening (or disabling) and major

Timepoint [12]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [13]

Acute kidney injury based on the Acute Kidney Injury Network (AKIN) System Stage 3 (including renal replacement therapy) or Stage 2

Timepoint [13]

=7 days post index procedure

Secondary outcome [14]

Major vascular complications major

Timepoint [14]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [15]

Repeat procedure for valve-related dysfunction (surgical or interventional therapy)

Timepoint [15]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [16]

Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)

Timepoint [16]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [17]

New permanent pacemaker implantation resulting from new or worsened conduction disturbances

Timepoint [17]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [18]

New onset of atrial fibrillation or atrial flutter

Timepoint [18]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [19]

Coronary obstruction

Timepoint [19]

=72 hours post index procedure

Secondary outcome [20]

Ventricular septal perforation

Timepoint [20]

=72 hours post index procedure

Secondary outcome [21]

Mitral apparatus damage

Timepoint [21]

=72 hours post index procedure

Secondary outcome [22]

Cardiac tamponade

Timepoint [22]

=72 hours post index procedure

Secondary outcome [23]

Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment

Timepoint [23]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [24]

Transcatheter aortic valve (TAV)-in-TAV deployment

Timepoint [24]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [25]

Prosthetic aortic valve thrombosis

Timepoint [25]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [26]

Prosthetic aortic valve endocarditis

Timepoint [26]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [27]

Neurological status per modified Rankin Scale score

Timepoint [27]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [28]

Neurological status per National Institutes of Health Stroke Scale

Timepoint [28]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Secondary outcome [29]

Functional Improvement from baseline per NYHA functional classification

Timepoint [29]

At discharge from hospital or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 12 months post procedure

Eligibility

Key inclusion criteria

1. Subject is =70 years of age
2. Subject has documented calcific native aortic valve stenosis with an initial aortic valve area (AVA) of =1.0 cm2 (or AVA index of =0.6 cm2/m2) and either a mean pressure gradient =40 mm Hg or a jet velocity =4 m/s, as measured by echocardiography.
3. Subject has a documented aortic annulus size between =20 and =27.5 mm based on pre-procedure diagnostic imaging
4. Subject has symptomatic aortic valve stenosis with NYHA Functional Class = II.
5. Subject is considered high risk for surgical valve replacement based on at least one of the following:

* Society of Thoracic Surgeons (STS) score =8%, and/or
* Agreement by the heart team (which must include an in-person evaluation by an experienced cardiac surgeon) that subject is at high operative risk of serious morbidity or mortality with surgical valve replacement.
6. Heart team (which must include an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement
7. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
8. Subject, family member and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.

Minimum age

70 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Subject has a congenital unicuspid or bicuspid aortic valve.
2. Subject with an acute myocardial infarction within 30 days of the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation = twice normal in the presence of creatine kinase-myoglobin band (CK-MB) elevation and/or troponin level elevation).
3. Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months, or has any permanent neurologic defect prior to study enrollment.
4. Subject is on dialysis or has serum creatinine level >3.0 mg/dL or 265 µml/L.
5. Subject has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic ring in any position.
6. Subject has =3+ mitral regurgitation, =3+ aortic regurgitation or =3+ tricuspid regurgitation (i.e., subject cannot have more than moderate mitral, aortic or tricuspid regurgitation).
7. Subject has a need for emergency surgery for any reason.
8. Subject has a history of endocarditis within 12 months of index procedure or evidence of an active systemic infection or sepsis.
9. Subject has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.
10. Subject has Hgb <9 g/dL, platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.
11. Subject is receiving chronic (=72 hours) anticoagulation therapy (warfarin), and cannot tolerate concomitant therapy with aspirin or clopidogrel (subjects who require chronic anticoagulation must additionally be able to be treated with either aspirin or clopidogrel).*
12. Subject has active peptic ulcer disease or gastrointestinal bleed within the past 3 months, other bleeding diathesis or coagulopathy or will refuse transfusions.
13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all thienopyridines, heparin, nickel, titanium, or polyurethanes.
14. Subject has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrollment.
15. Subject has hypertrophic obstructive cardiomyopathy.
16. Subject has any therapeutic invasive cardiac procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty and pacemaker implantation which are allowed).
17. Subject has untreated coronary artery disease, which in the opinion of the treating physician, is clinically significant and requires revascularization.
18. Subject has documented left ventricular ejection fraction <30%.
19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
20. Subject has severe peripheral vascular disease (including aneurysm defined as maximal luminal diameter >5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick [>5 mm] protruding or ulcerated atheroma in the aortic arch) or symptomatic carotid or vertebral disease.
21. Femoral artery lumen of <6.0 mm for subjects requiring 23 mm valve size or <6.5 mm for subjects requiring 27 mm valve size, or severe iliofemoral tortuosity or calcification that would prevent safe placement of the introducer sheath.
22. Current problems with substance abuse (e.g., alcohol, etc.).
23. Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
24. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation.

Study design

Purpose of the study

Treatment

Allocation to intervention

Not applicable

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

3/12/2014

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

19/10/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD,VIC

Recruitment hospital [1]

Prince Charles Hospital - Chermside

Recruitment hospital [2]

Monash Heart - Clayton

Recruitment postcode(s) [1]

4032 - Chermside

Recruitment postcode(s) [2]

3168 - Clayton

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Boston Scientific Corporation

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

To confirm the acute performance and safety of the Lotus™ Valve with the Next Generation Delivery System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

Trial website

https://clinicaltrials.gov/study/NCT02329496

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Robert Gooley, MD

Address

Monash

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02329496

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02329496