Brief Summary
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Brief Title
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Detailed Description
A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
(949) 250-2500
Central Contact Email
TMTT_Clinical@edwards.com
Completion Date
Completion Date Type
Estimated
Conditions
Degenerative Mitral Valve Disease
Mitral Regurgitation
Mitral Insufficiency
Functional Mitral Regurgitation
Eligibility Criteria
Inclusion Criteria:
* Eighteen (18) years of age or older
* Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
* Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).
* Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
* Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
* Mitral regurgitation (3+ to 4+) by echo
* Suitable valve and regurgitant jet morphology
* Elevated corrected BNP \> 400 pg/ml or corrected NT-pro BNP of \> 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)
* LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)
Exclusion Criteria:
* Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
* Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
* Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure)
* Clinically significant, untreated coronary artery disease
* Recent stroke
* Other severe valve disorders requiring intervention
* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
* Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)
* Severe tricuspid regurgitation or tricuspid valve disease requiring surgery
* Active rheumatic heart disease or rheumatic etiology for MR
* Severe aortic stenosis or regurgitation
* Known history of untreated, severe carotid stenosis
* Recent deep vein thrombosis (DVT) or pulmonary embolism (PE)
* Severe COPD
* Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception
* Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
* Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment
* Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship
* Eighteen (18) years of age or older
* Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
* Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).
* Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
* Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
* Mitral regurgitation (3+ to 4+) by echo
* Suitable valve and regurgitant jet morphology
* Elevated corrected BNP \> 400 pg/ml or corrected NT-pro BNP of \> 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)
* LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)
Exclusion Criteria:
* Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
* Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
* Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure)
* Clinically significant, untreated coronary artery disease
* Recent stroke
* Other severe valve disorders requiring intervention
* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
* Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)
* Severe tricuspid regurgitation or tricuspid valve disease requiring surgery
* Active rheumatic heart disease or rheumatic etiology for MR
* Severe aortic stenosis or regurgitation
* Known history of untreated, severe carotid stenosis
* Recent deep vein thrombosis (DVT) or pulmonary embolism (PE)
* Severe COPD
* Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception
* Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
* Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment
* Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship
Inclusion Criteria
Inclusion Criteria:
* Eighteen (18) years of age or older
* Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
* Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).
* Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
* Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
* Mitral regurgitation (3+ to 4+) by echo
* Suitable valve and regurgitant jet morphology
* Elevated corrected BNP \> 400 pg/ml or corrected NT-pro BNP of \> 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)
* LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)
* Eighteen (18) years of age or older
* Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
* Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).
* Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
* Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
* Mitral regurgitation (3+ to 4+) by echo
* Suitable valve and regurgitant jet morphology
* Elevated corrected BNP \> 400 pg/ml or corrected NT-pro BNP of \> 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)
* LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03706833
Org Class
Industry
Org Full Name
Edwards Lifesciences
Org Study Id
2018-07
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation
Primary Outcomes
Outcome Measure
PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs).
Outcome Time Frame
30 days.
Outcome Measure
PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort.
Outcome Time Frame
6 months
Outcome Measure
PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only.
Outcome Time Frame
From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up
Secondary Outcomes
Outcome Description
Rates of various adverse events at 6 and 12 months
Outcome Time Frame
6 months; 12 months
Outcome Measure
Rates of various adverse events
Outcome Description
Increase in 6 minute walk test in meters
Outcome Time Frame
30 days , 6 months, 1 year
Outcome Measure
Functional Improvement (increase in 6 minute walk test in meters)
Outcome Description
Number of points of improvement on a scale of 0-100 in Kansas City Cardiomyopathy Questionnaire, with higher scores associated with higher Quality of Life
Outcome Time Frame
30 days , 6 months, 1 year, 2 year
Outcome Measure
Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years
Outcome Description
Number of points of improvement on a scale of 0-100 in Short Form Health Survey (SF-36) questionnaire, with higher totals associated with higher Quality of Life
Outcome Time Frame
30 days, 6 months, 1 year, 2 year
Outcome Measure
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire through 2 years
Outcome Description
Number of points of improvement on a scale of 1-100 in Short Form Health Survey (EQ-5D-5L) questionnaire, with higher totals associated with higher Quality of Life
Outcome Time Frame
30 days, 6 months, 1 year, 2 year
Outcome Measure
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mohamed Azeem Latib
Investigator Email
mlatib@montefiore.org
Investigator Phone
646-773-2076