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OpenTrials
Completed

NCT Number: NCT01841554

Cardioband With Transfemoral Delivery System

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

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Bichat-Claude Bernard, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardioband

Device

Other names: With Transfemoral delivery system

Primary outcomes

  1. Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects

    Time frame: 30 days

    Overall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days.

Secondary outcomes

  1. Performance [6MWT]

    Time frame: Baseline, 6 and 12 months

    Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months.

  2. Performance [MLHFQ]

    Time frame: Baseline, 6 and 12 months

    Score on Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is composed of 21 questions relating to limitations in lifestyle associated with heart failure. Respondents use a 5 point scale from 0 to 5, with a 0 representing no limitation and 5 representing maximum limitation. The total score is computed by adding individual scores of each question. Higher scores are associated with lower quality of life.

  3. Performance [Intra-subject Comparison - MR Severity]

    Time frame: Baseline, discharge, 6 and 12 months

    All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).

  4. Performance [Full Analysis Data Set - MR Severity]

    Time frame: Baseline, discharge, 6 and 12 months

    All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).

Other outcomes

  1. Reduce MR [Paired Baseline and Follow-Up]

    Time frame: Post-adjustment, discharge, and 30 Days

    Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure, at hospital discharge, and at 30 days. Reported as number of patients showing a reduction in MR grade greater than or equal to 1.

  2. Technical Feasibility of Cardioband Adjustment

    Time frame: Immediately after procedure

    The ability to connect the Adjustment Tool, reduce septo-lateral dimension, and retract the Adjustment Tool with guide wire.

  3. Technical Success Rate of the Implantation of the Cardioband

    Time frame: Immediately after implantation

    The ability to advance the implant, load anchors, anchor the implant to tissue, and retract the Implant Delivery System.

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation

Important dates

Study start
2011
Primary completion
2016
Study completion
2018
First posted
Apr 26, 2013
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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