Mitral Valve Regurgitation
The purpose of this study is to assess the safety and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.
- Device: Mitral Valve RepairMinimal Invasive Transcatheter Mitral Valve Repair
|Ages eligible for Study||18 Years and older|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||No|
- Signed and dated 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 heart failure de-spite optimal medical therapy
- Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
- Patient able to perform a six-minute walk test (6MWT).
- 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.
- Subject agrees to return for all required post-procedure follow-up visits
- 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.
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction
- Untreated significant coronary artery disease / stenosis, evidence of acute coronary syndrome, myocardial infarction, transient ischemic attack or stroke within 30 days prior to intervention
- Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery or atrial fibrillation ablation within 90 days prior to intervention
- Any prior mitral valve surgery or transcatheter mitral valve procedure
- Contraindication to transseptal catheterization
- Active endocarditis or active infections requiring current antibiotic therapy or last antibiotic treatment was administered within 14 days prior to intervention
- Active rheumatic heart disease or rheumatic etiology for MR
The purpose of this study is to assess the safety and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System. This is a multi-center, multi-national, prospective, single arm, safety and clinical outcomes study.
- Metro North Hospital & Health Service, The Prince Charles HospitalrecruitingBrisbane, Chermside, Australia, QLD 4032
- Sydney Local Health District, Royal Prince Alfred HospitalrecruitingCamperdown, New South Wales, Australia, 2050
- St. Paul's Hospital, Providence Health Care Research Institutenot yet recruitingVancouver, British Columbia, Canada, V6E 1M7
- Sunnybrook Hospitalnot yet recruitingToronto, Ontario, Canada, M4N 3M5
- St Michael Hospitalnot yet recruitingToronto, Ontario, Canada, M5B-1W8
26 June, 2017
06 September, 2017