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

Investigator(s)

William Hiesinger, MD
William Hiesinger, MD
Cardiac surgeon, Cardiovascular surgeon, Cardiothoracic surgeon, General surgeon, Lung transplant surgeon
Assistant Professor of Cardiothoracic Surgery (Adult Cardiac Surgery)
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)
Rahul P Sharma, MBBS, FRACP
Rahul P Sharma, MBBS, FRACP
Cardiologist, Interventional cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine
Albert Cheung
Albert Cheung
Anesthesiologist
Professor of Anesthesiology, Perioperative and Pain Medicine (Cardiac)
Christiane Haeffele
Christiane Haeffele
Cardiologist, Adult congenital heart disease cardiologist
Clinical Assistant 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

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