NL-OMON46895
Completed
Not Applicable
Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation - Cardioband For Transcatheter MV Repair
Valtech Cardio LTD0 sites10 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- mitral valve regurgitation
- Sponsor
- Valtech Cardio LTD
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Age \> 18 years
- •\* Moderate to severe functional MR
- •\* Symptomatic Patients (NYHA ClassII\-IV) despite optimal medical therapy , including CRT if indicated.
- •\* LVEF \* 25%, LVEDD \* 70mm
- •\* Subject is high risk to undergo MV surgery (as assessed by a cardiac surgeon and a cardiologist at the site, and according to ESC/EACTS guidelines on the management of valvular heart disease)
- •\* 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 CAD requiring revascularization
- •\* Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
- •\* CVA or TIA within 6 months or severe carotid stenosis (\>70% by Ultra sound)
- •\* Renal insufficiency requiring dialysis
- •\* Life expectancy of less than twelve months
- •\* Patient is pregnant (urine HCG test result positive) or lactating
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Cardioband With Transfemoral Delivery SystemMitral RegurgitationNCT01841554Edwards Lifesciences62
Unknown
Phase 2
Dynamic Annuloplasty System With Activation for the Treatment of Mitral RegurgitationMitral Valve RegurgitationNCT00833014MiCardia Corporation130
Completed
Not Applicable
Mitral Adjustable Annuloplasty Ring Feasibility and Safety StudyNL-OMON31130MitralSolutions, Inc.20
Completed
Not Applicable
CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral RegurgitationMitral Valve InsufficiencyNCT01137734Edwards Lifesciences30
Completed
Not Applicable
aparoscopic adjustable banded gastric plication in morbid obesityMorbid obesitySurgeryObesityISRCTN17213539E-DA Hospital (Taiwan)100