This trial is active, not recruiting.

Condition mitral valve insufficiency
Treatment cardioband adjustable band
Sponsor Valtech Cardio Ltd
Start date September 2011
End date July 2016
Trial size 16 participants
Trial identifier NCT01533883, CB1-1


Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a transfemoral delivery system. The aim of this study is to evaluate the performance and safety of the Cardioband for repair of mitral regurgitation.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

time frame: 30 days
Technical success rate of the implantation of the Cardioband
time frame: Immedietly after implantation
Technical feasibility of Cardioband adjustment
time frame: Immedietly after procedure
Reduce MR
time frame: 30 days

Secondary Outcomes

time frame: 12 months
time frame: 6 and 12 months
time frame: 6 and 12 months
time frame: 6 and 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 ≤ 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 requiband 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 requiband dialysis - Life expectancy of less than twelve months - Patient is pregnant (urine HCG test result positive) or lactating - Known sensitivity to Nickel or Chromium - Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically - Bleeding or clotting disorders - Subject is participating in concomitant research studies of investigational products - Pulmonary hypertension >70mmHg at rest - 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 Minimally Invasive Mitral Valve Repair
Principal investigator Ottavio Alfieri, MD
Description The current state of the art management of severe mitral regurgitation is surgical mitral valve repair, either with open chest surgery or mini-thoracotomy. However, standard surgical approaches requiring cardiopulmonary bypass are reserved to fit patients with low or moderate surgical risk, and thus several patients are refused surgery because of unfavorable risk-benefit balance. Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a transfemoral delivery system. Cardioband is intended to remodel the annulus by deployment and fixation along (and direct) the posterior annulus of the mitral valve, in order to correct mitral regurgitation. Adjustment can be performed on a beating heart, to optimize correction of mitral regurgitation.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Valtech Cardio Ltd.