Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

Trial ID or NCT#

NCT03706833

Status

recruiting iconRECRUITING

Purpose

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)

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

William Hiesinger, MD
William Hiesinger, MD
Cardiothoracic surgeon
Associate Professor of Cardiothoracic Surgery (Adult Cardiac Surgery)
Christiane Haeffele
Christiane Haeffele
Cardiologist, Adult congenital heart disease cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology
Yasuhiro Shudo, MD, PhD
Yasuhiro Shudo, MD, PhD
Cardiothoracic surgeon, Cardiac surgeon, Cardiovascular surgeon, Lung transplant surgeon
Clinical Assistant Professor, Cardiothoracic Surgery
Jack Boyd
Jack Boyd
Cardiac surgeon, Cardiothoracic surgeon, Heart transplant surgeon, Heart and lung transplant surgeon, Vascular surgeon, Cardiovascular surgeon, Lung transplant surgeon
Clinical Associate Professor, Cardiothoracic Surgery
Albert Cheung
Albert Cheung
Anesthesiologist
Professor of Anesthesiology, Perioperative and Pain Medicine (Cardiac)
Rahul P Sharma, MBBS, FRACP
Rahul P Sharma, MBBS, FRACP
Cardiologist, Interventional cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine
David Lee, MD
David Lee, MD
Cardiologist, Interventional cardiologist
Professor of Medicine (Cardiovascular Medicine)
William Fearon, MD
William Fearon, MD
Interventional cardiologist, Cardiologist
Professor of Medicine (Cardiovascular Medicine)