Clinical trial NCT03170349: The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
Official title: The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mitral Valve Regurgitation
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2017-05-31
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System. This is a multi-center, multi-national, prospective, single arm, safety, performance and clinical outcomes study.

Eligibility criteria: 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.

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

Primary outcomes:
measure: Number of Participants With Major Adverse Events (MAE)
timeFrame: 30 days
measure: Device Success
timeFrame: Exit from the cardiac catheterization laboratory
measure: Number of Participants With Procedural Success
timeFrame: through discharge
measure: Clinical Success
timeFrame: 30 days
Secondary outcomes:
measure: Mitral Regurgitation Reduction
timeFrame: Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years
measure: All-cause Mortality
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years
measure: Recurrent Heart Failure Hospitalization
timeFrame: 30 days , 6 months, 1 year, 2 year, 3 year
measure: Reintervention Rates for Mitral Regurgitation
timeFrame: 30 days, 6 months, 1 year, 2 year, 3 year
measure: Composite of Major Adverse Events (MAEs) Defined as Cardiovascular Mortality, Stroke, Myocardial Infarction, New Need for Renal Replacement Therapy, Severe Bleeding and Reintervention for Study Device Related Complications
timeFrame: 6 months, 1 year, 2 year, 3 year
measure: LVEDV by Study Visit
timeFrame: Baseline, 6 Months, 1 Year, 2 Years and 3 Years
measure: Change in LVEDV, Baseline to 6-Month Visit
timeFrame: Baseline and 6 Months
measure: Change in LVEDV, Baseline to 1-Year Visit
timeFrame: Baseline and 1 Year
measure: Change in LVEDV, Baseline to 2-Year Visit
timeFrame: Baseline and 2 Years
measure: Change in LVEDV, Baseline to 3-Year Visit
timeFrame: Baseline and 3 Years
measure: LVESV by Study Visit
timeFrame: Baseline, 6 Months, 1 Year, 2 Years and 3 Years
measure: Change in LVESV, Baseline to 6-Month Visit
timeFrame: Baseline and 6 Months
measure: Change in LVESV, Baseline to 1-Year Visit
timeFrame: Baseline and 1 Year
measure: Change in LVESV, Baseline to 2-Year Visit
timeFrame: Baseline and 2 Years
measure: Change in LVESV, Baseline to 3-Year Visit
timeFrame: Baseline and 3 Years
measure: PASP by Study Visit
timeFrame: Baseline, 6 Months, 1 Year, 2 Years and 3 Years
measure: Change in PASP, Baseline to 6-Month Visit
timeFrame: Baseline and 6 Months
measure: Change in PASP, Baseline to 1-Year Visit
timeFrame: Baseline and 1 Year
measure: Change in PASP, Baseline to 2-Year Visit
timeFrame: Baseline and 2 Years
measure: Change in PASP, Baseline to 3-Year Visit
timeFrame: Baseline and 3 Years
measure: 6MWD by Study Visit
timeFrame: Baseline, 6 Months and 1 Year
measure: Change in 6MWD, Baseline to 6-Month Visit
timeFrame: Baseline and 6 Months
measure: Change in 6MWD, Baseline to 1-Year Visit
timeFrame: Baseline and 1 Year
measure: Change in NYHA Functional Classification
timeFrame: Baseline, 6 Months, 1 Year, 2 Years, 3 Years
measure: KCCQ OS Score by Study Visit
timeFrame: Baseline, 30 Days, 6 Months and 1 Year
measure: Change in KCCQ OS Score, Baseline to 30-Day Visit
timeFrame: Baseline and 30 Days
measure: Change in KCCQ OS Score, Baseline to 6-Month Visit
timeFrame: Baseline and 6 Months
measure: Change in KCCQ OS Score, Baseline to 1-Year Visit
timeFrame: Baseline and 1 Year
measure: EQ5D VAS Score by Study Visit
timeFrame: Baseline, 30 Days, 6 Months and 1 Year
measure: Change in EQ5D VAS Score, Baseline to 30-Day Visit
timeFrame: Baseline and 30 Days
measure: Change in EQ5D VAS Score, Baseline to 6-Month Visit
timeFrame: Baseline and 6 Months
measure: Change in EQ5D VAS Score, Baseline to 1-Year Visit
timeFrame: Baseline and 1 Year
measure: NT-proBNP by Study Visit
timeFrame: Baseline, 6 Months, 1 Year, 2 Years and 3 Years
measure: Change in NT-proBNP, Baseline to 6-Month Visit
timeFrame: Baseline and 6 Months
measure: Change in NT-proBNP, Baseline to 1-Year Visit
timeFrame: Baseline and 1 Year
measure: Change in NT-proBNP, Baseline to 2-Year Visit
timeFrame: Baseline and 2 Years
measure: Change in NT-proBNP, Baseline to 3-Year Visit
timeFrame: Baseline and 3 Years
measure: BNP by Study Visit
timeFrame: Baseline, 6 Months, 1 Year, 2 Years and 3 Years
measure: Change in BNP, Baseline to 6-Month Visit
timeFrame: Baseline and 6 Months
measure: Change BNP, Baseline to 1-Year Visit
timeFrame: Baseline and 1 Year
measure: Change in BNP, Baseline to 2-Year Visit
timeFrame: Baseline and 2 Years
measure: Change in BNP, Baseline to 3-Year Visit
timeFrame: Baseline and 3 Years
measure: Change in Tricuspid Regurgitation From Baseline
timeFrame: 6 Month, 1 Year, 2 Years, 3 Years
measure: Mitral EROA by Study Visit
timeFrame: Baseline, 30 Days, 6 Months, 1 Year, 2 Years and 3 Years
measure: Change in Mitral EROA, Baseline to 30-Day Visit
timeFrame: Baseline and 30 Days
measure: Change in Mitral EROA, Baseline to 6-Month Visit
timeFrame: Baseline and 6 Months
measure: Change in Mitral EROA, Baseline to 1-Year Visit
timeFrame: Baseline and 1 Year
measure: Change in Mitral EROA, Baseline to 2-Year Visit
timeFrame: Baseline and 2 Years
measure: Change in Mitral EROA, Baseline to 3-Year Visit
timeFrame: Baseline and 3 Years
measure: Mitral Regurgitant Volume by Study Visit
timeFrame: Baseline, 30 Days, 6 Months, 1 Year, 2 Years and 3 Years
measure: Change in Mitral Regurgitant Volume, Baseline to 30-Day Visit
timeFrame: Baseline and 30 Days
measure: Change in Mitral Regurgitant Volume, Baseline to 6-Month Visit
timeFrame: Baseline and 6 Months
measure: Change in Mitral Regurgitant Volume, Baseline to 1-Year Visit
timeFrame: Baseline and 1 Year
measure: Change in Mitral Regurgitant Volume, Baseline to 2-Year Visit
timeFrame: Baseline and 2 Years
measure: Change in Mitral Regurgitant Volume, Baseline to 3-Year Visit
timeFrame: Baseline and 3 Years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Brisbane
country: Australia
facility: Metro North Hospital & Health Service, The Prince Charles Hospital
state: Chermside
city: Camperdown
country: Australia
facility: Sydney Local Health District, Royal Prince Alfred Hospital
state: New South Wales
city: Vancouver
country: Canada
facility: St. Paul's Hospital, Providence Health Care Research Institute
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Hospital
state: Ontario
city: Toronto
country: Canada
facility: St Michael Hospital
state: Ontario
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn, Medizinische Klinik II, Kardiologie
city: Athens
country: Greece
facility: Hygeia Hospital
city: Milano
country: Italy
facility: San Rafaelle Hospital
city: Bern
country: Switzerland
facility: Inselspital, University Hospital Bern
Study officials:
affiliation: Sunnybrook Hospital
name: Gideon Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BundeswehrZentralkrankenhaus Koblenz
name: Ulrich Schafer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Heart Hospital Baylor
name: Molly Szerlip, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.