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Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Valtech Cardio Ltd
ClinicalTrials.gov Identifier:
NCT01533883
First received: February 7, 2012
Last updated: August 28, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
Mitral Valve Insufficiency
Device: Cardioband adjustable band

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair

Further study details as provided by Valtech Cardio Ltd:

Primary Outcome Measures:
  • safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Overall rate of Serious adverse events (SAEs) and serious adverse device effects (SADE) until hospital discharge and at post-operative 30 days.

  • Technical success rate of the implantation of the Cardioband [ Time Frame: Immedietly after implantation ] [ Designated as safety issue: No ]
  • Technical feasibility of Cardioband adjustment [ Time Frame: Immedietly after procedure ] [ Designated as safety issue: No ]
  • Reduce MR [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Cardioband ability to reduce mitral valve regurgitation (MR) post-procedure, at post-operative hospital discharge, and at post-operative 30 days.


Secondary Outcome Measures:
  • safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Overall rate of Serious adverse events (SAEs) and serious adverse device effects (SADE)will be compared to the literature.

  • Performance [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Change in MR severity in 6 and 12 months

  • Performance [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Change in 6 MWT in 6 and 12 months

  • Performance [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Change in quality of life questionnaire (MLHFQ) in 6 and 12 months


Enrollment: 16
Study Start Date: September 2011
Estimated Study Completion Date: June 2018
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Cardioband adjustable band
    Cardioband is an adjustable sutureless annuloplasty band designed for mitral valve repair by a transfemoral approach. Cardioband is intended to remodel the annulus by deployment and fixation along 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.
Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient is a candidate for mitral valve repair: moderate to severe mitral regurgitation, symptomatic or asymptomatic with evidence of left ventricular dysfunction (AHA/ACC criteria)
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533883

Locations
Italy
Ospedale Ferrarotto Alessi
Catania, Italy
Hospital san raffaele
Milano, Italy, 20132
Sponsors and Collaborators
Valtech Cardio Ltd
Investigators
Principal Investigator: Ottavio Alfieri, MD Hospital San Raffaele, Milan, Italy
Principal Investigator: Michael Borger, MD PhD Heart Center Leipzig, Leipzig, Germany
  More Information

Responsible Party: Valtech Cardio Ltd
ClinicalTrials.gov Identifier: NCT01533883     History of Changes
Other Study ID Numbers: CB1-1 
Study First Received: February 7, 2012
Last Updated: August 28, 2016
Health Authority: Italy: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Valtech Cardio Ltd:
Mitral
Valve
Annuloplasty
Transatrial
Transapical
Transfemoral
Mitral valve insufficiency

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2016