N/A
N=61
Cardioband With Transfemoral Delivery System
Mitral Regurgitation
Bottom Line
View on ClinicalTrials.gov: NCT01841554 ↗Enrolled (actual)
61
Serious AEs
71.0%
Results posted
Mar 2020
Primary outcome: Primary: Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects — 2; 1; 2; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cardioband (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects |
2; 1; 2; 4; 1; 0 | — |
| SECONDARY Performance [6MWT] |
334.7778; 393.2222; 407.0556 | — |
| SECONDARY Performance [MLHFQ] |
35.8889; 16.2593; 19.3333 | — |
| SECONDARY Performance [Intra-subject Comparison - MR Severity] |
16; 10; 0; 1; 5; 20 | — |
| SECONDARY Performance [Full Analysis Data Set - MR Severity] |
45; 16; 0; 6; 13; 39 | — |
Summary
To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01841554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.