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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

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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03170349