Status:
COMPLETED
Cardioband With Transfemoral Delivery System
Lead Sponsor:
Edwards Lifesciences
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.
Eligibility Criteria
Inclusion
- Age \> 18 years
- Moderate to severe functional Mitral Regurgitation (MR)
- Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including Cardiac Resynchronization (CRT) if indicated.
- Left Ventricle Ejection Fraction (LVEF) ≥ 25%, LVEDD ≤ 65mm
- Subject is high risk to undergo Mitral Valve (MV) surgery (as assessed by a surgeon and a cardiologist, at the site)
- Transseptal catheterization and femoral vein access is determined to be feasible
- Subject is able and willing to give informed consent and follow protocol procedures
Exclusion
- Active bacterial endocarditis
- Severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue
- Heavily calcified annulus or leaflets
- Subjects in whom transesophageal echocardiography is contraindicated
- Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
- CRT implant within 3 months prior to procedure
- Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
- Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 6 months or severe carotid stenosis (\>70% by Ultra sound)
- Renal insufficiency requiring dialysis
- Life expectancy of less than twelve months
- Subject is participating in concomitant research studies of investigational products
- Mitral valve anatomy which may preclude proper device treatment
- Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and severe tricuspid regurgitation
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01841554
Start Date
September 1 2011
End Date
June 1 2018
Last Update
November 30 2020
Active Locations (11)
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1
Hôpital Bichat-Claude Bernard
Paris, France, 75877
2
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II
Bonn, Germany, 53105
3
Universitätskliniken zu Köln Klinik III Innere Medizin
Cologne, Germany, 50937
4
Asklepios Klinik, St. Georg
Hamburg, Germany, 20099