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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03170349




Registration number
NCT03170349
Ethics application status
Date submitted
26/05/2017
Date registered
31/05/2017
Date last updated
3/05/2024

Titles & IDs
Public title
The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
Scientific title
The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
Secondary ID [1] 0 0
2016-05
Universal Trial Number (UTN)
Trial acronym
CLASP
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Mitral Valve Repair

Experimental: Edwards PASCAL Transcatheter Mitral Valve Repair System -


Treatment: Devices: Mitral Valve Repair
Minimal Invasive Transcatheter Mitral Valve Repair
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Major Adverse Events (MAE)
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Device Success
Timepoint [2] 0 0
Exit from the cardiac catheterization laboratory
Primary outcome [3] 0 0
Number of Participants With Procedural Success
Timepoint [3] 0 0
through discharge
Primary outcome [4] 0 0
Clinical Success
Timepoint [4] 0 0
30 days
Secondary outcome [1] 0 0
Mitral Regurgitation Reduction
Timepoint [1] 0 0
baseline, 30 days, 6 months, 1 year, 2 year
Secondary outcome [2] 0 0
All-cause Mortality
Timepoint [2] 0 0
30 days, 6 months, 1 year, 2 year
Secondary outcome [3] 0 0
Recurrent Heart Failure Hospitalization
Timepoint [3] 0 0
30 days , 6 months, 1 year, 2 year
Secondary outcome [4] 0 0
Re-intervention Rates for Mitral Regurgitation
Timepoint [4] 0 0
30 days, 6 months, 1 year, 2 year
Secondary outcome [5] 0 0
Composite of Major Adverse Events (MAE) Defined as Cardiovascular Mortality, Stroke, Myocardial Infarction, New Need for Renal Replacement Therapy, Severe Bleeding and Re-intervention for Study Device Related Complications
Timepoint [5] 0 0
6 months, 1 year, 2 year
Secondary outcome [6] 0 0
Change in Left Ventricular End Diastolic Volume (LVEDV)
Timepoint [6] 0 0
6 months, 1 year, 2 year
Secondary outcome [7] 0 0
Change in Left Ventricular End Systolic Volume (LVESV)
Timepoint [7] 0 0
6 months, 1 year, 2 year
Secondary outcome [8] 0 0
Change in Pulmonary Artery Systolic Pressure
Timepoint [8] 0 0
baseline, 6 months, 1 year
Secondary outcome [9] 0 0
Change in Six Minute Walk Test (6MWT) Distance
Timepoint [9] 0 0
6 months, 1 year
Secondary outcome [10] 0 0
Change in Quality of Life (QoL) Score, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Timepoint [10] 0 0
baseline, 30 days, 6 months, 1 year
Secondary outcome [11] 0 0
Change in Quality of Life (QoL) Score, as Measured by EQ5D
Timepoint [11] 0 0
baseline, 30 days, 6 months, 1 year
Secondary outcome [12] 0 0
Change in NYHA Functional Classification
Timepoint [12] 0 0
baseline, 6 months, 1 year, 2 year
Secondary outcome [13] 0 0
Change NT-pro-BNP Level
Timepoint [13] 0 0
baseline, 6 months, 1 year, 2 year
Secondary outcome [14] 0 0
Change in BNP Level
Timepoint [14] 0 0
baseline, 6 months, 1 year, 2 year
Secondary outcome [15] 0 0
Change in Tricuspid Regurgitation (TR) at 6 Months, 1 Year and Annually Thereafter Over Baseline
Timepoint [15] 0 0
6 months, 1 year, 2 year
Secondary outcome [16] 0 0
Change in Effective Regurgitant Orifice Area (EROA)
Timepoint [16] 0 0
baseline, 30 days, 6 months, 1 year, 2 year
Secondary outcome [17] 0 0
Change in Mitral Regurgitant Volume
Timepoint [17] 0 0
baseline, 30 days, 6 months, 1 year, 2 year

Eligibility
Key inclusion criteria
* Signed and dated IRB/ethics committee approved study consent form prior to study related procedures
* Eighteen (18) years of age or older
* New York Heart Association (NYHA) Functional Class II-IVa heart failure despite optimal medical therapy
* Candidacy for surgical mitral valve repair or replacement determined by Heart Team evaluation
* Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
* The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant.
* Mitral valve area (MVA) = 4.0 cm² as measured by planimetry. If MVA by planimetry is not measurable, pressure half-time measurement is acceptable.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
* Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation.
* Mitral valve area (MVA) < 4.0 cm² as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable)
* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
* Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction
* Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
* Patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment
* Patient is under guardianship

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
ChermsideNSW
Recruitment hospital [1] 0 0
Metro North Hospital & Health Service, The Prince Charles Hospital - Brisbane
Recruitment hospital [2] 0 0
Sydney Local Health District, Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 0 0
QLD 4032 - Brisbane
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Germany
State/province [11] 0 0
Bonn
Country [12] 0 0
Greece
State/province [12] 0 0
Athens
Country [13] 0 0
Italy
State/province [13] 0 0
Milano
Country [14] 0 0
Switzerland
State/province [14] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Edwards Lifesciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.
Trial website
https://clinicaltrials.gov/study/NCT03170349
Trial related presentations / publications
Webb JG, Hensey M, Szerlip M, Schafer U, Cohen GN, Kar S, Makkar R, Kipperman RM, Spargias K, O'Neill WW, Ng MKC, Fam NP, Rinaldi MJ, Smith RL, Walters DL, Raffel CO, Levisay J, Latib A, Montorfano M, Marcoff L, Shrivastava M, Boone R, Gilmore S, Feldman TE, Lim DS. 1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study. JACC Cardiovasc Interv. 2020 Oct 26;13(20):2344-2357. doi: 10.1016/j.jcin.2020.06.019.
Lim DS, Kar S, Spargias K, Kipperman RM, O'Neill WW, Ng MKC, Fam NP, Walters DL, Webb JG, Smith RL, Rinaldi MJ, Latib A, Cohen GN, Schafer U, Marcoff L, Vandrangi P, Verta P, Feldman TE. Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study. JACC Cardiovasc Interv. 2019 Jul 22;12(14):1369-1378. doi: 10.1016/j.jcin.2019.04.034. Epub 2019 Jun 26.
Public notes

Contacts
Principal investigator
Name 0 0
Gideon Cohen, MD
Address 0 0
Sunnybrook Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03170349