Edwards PASCAL TrAnScatheter Mitral Valve RePair System Pivotal Clinical Trial (CLASP IID): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Mitral Valve Repair System Compared to Abbott MitraClip in Patients With Degenerative Mitral Regurgitation (DMR).
This is Study to establish the safety and effectiveness of the Edwards PASCAL Transcatheter Mitral Valve Repair System in patients with degenerative mitral regurgitation (DMR). Patients who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.
This Study is a Edwards PASCAL TrAnScatheter Mitral Valve RePair System Pivotal Clinical Trial (CLASP IID): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Mitral Valve Repair System Compared to Abbott MitraClip in Patients With Degenerative Mitral Regurgitation (DMR);
This Study is a prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Mitral Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.
Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
- Eighteen (18) years of age or older
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Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements
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Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team
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Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
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Mitral regurgitation (3+ to 4+) by echo
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Suitable valve and regurgitant jet morphology
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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%
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- Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
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Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
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End-stage Heart Failure with inotrope support or consideration for LVAD or heart transplant
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Clinically significant, untreated coronary artery disease
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Other severe valve disorders requiring intervention
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Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
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Any prior mitral valve surgery or transcatheter mitral valve procedure
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Active rheumatic heart disease or rheumatic etiology for MR
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Severe aortic stenosis or regurgitation
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Known history of severe symptomatic carotid stenosis
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History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
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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
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Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
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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
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Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship
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Mitral Valve Insufficiency
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