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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01841554 |
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Date of registration:
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23/04/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cardioband With Transfemoral Delivery System
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Scientific title:
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Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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62 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01841554 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Germany
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Israel
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Italy
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Netherlands
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Switzerland
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Contacts
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Name:
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Francesco Maisano, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitätsspital Zürich |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Mitral Regurgitation
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Intervention(s)
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Device: Cardioband
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Primary Outcome(s)
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Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects
[Time Frame: 30 days]
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Secondary Outcome(s)
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Performance [MLHFQ]
[Time Frame: Baseline, 6 and 12 months]
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Performance [6MWT]
[Time Frame: Baseline, 6 and 12 months]
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Performance [Intra-subject Comparison - MR Severity]
[Time Frame: Baseline, discharge, 6 and 12 months]
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Performance [Full Analysis Data Set - MR Severity]
[Time Frame: Baseline, discharge, 6 and 12 months]
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Secondary ID(s)
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CB1-1/CB1-2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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