Overview

This trial is active, not recruiting.

Condition mitral regurgitation
Treatment cardioband
Sponsor Valtech Cardio Ltd
Start date April 2013
End date July 2016
Trial size 51 participants
Trial identifier NCT01841554, CB1-2

Summary

To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cardioband With Transfemoral delivery system

Primary Outcomes

Measure
Safety • Overall rate of Major Serious Adverse Events (SAEs) and serious adverse safety
time frame: 30 days

Secondary Outcomes

Measure
Performance
time frame: up to 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 ≤ 65mm - Subject is high risk to undergo 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 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 - 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 - 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

Additional Information

Official title Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Valtech Cardio Ltd.