Mitral Valve Regurgitation
The purpose of this study is to assess the safety, performance 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 IRB/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-IVa heart failure despite optimal medical therapy
- Candidacy for surgical mitral valve repair or replacement determined by Heart Team evaluation
- Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
- 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.
- 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.
- Mitral valve area (MVA) < 4.0 cm² as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable)
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
- Patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment
- Patient is under guardianship
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System. This is a multi-center, multi-national, prospective, single arm, safety, performance and clinical outcomes study.
United States (2)
- NorthShore University HealthSystemrecruitingEvanston, Illinois, United States, 60201
- University of Virginia Health SystemrecruitingCharlottesville, Virginia, United States, 22908
- 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 InstituterecruitingVancouver, British Columbia, Canada, V6E 1M7
- Sunnybrook HospitalrecruitingToronto, Ontario, Canada, M4N 3M5
- St Michael HospitalrecruitingToronto, Ontario, Canada, M5B-1W8
- San Rafaelle HospitalrecruitingMilano, Italy, 20132
26 June, 2017
14 December, 2017