Cardioband With Transfemoral Delivery System

This study is currently recruiting participants.
Verified April 2013 by Valtech Cardio Ltd
Sponsor:
Information provided by (Responsible Party):
Valtech Cardio Ltd
ClinicalTrials.gov Identifier:
NCT01841554
First received: April 23, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

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


Condition Intervention
Mitral Regurgitation
Device: Cardioband

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation

Further study details as provided by Valtech Cardio Ltd:

Primary Outcome Measures:
  • Safety • Overall rate of Major Serious Adverse Events (SAEs) and serious adverse safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

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

    * Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke



Secondary Outcome Measures:
  • Performance [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    • MR Severity at 6 and 12 months
    • Change in 6 MWT in 6 and 12 months
    • Change in quality of life (MLHFQ) at 6 and 12 months


Other Outcome Measures:
  • Performance [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    • Technical success rate of the implantation of the Cardioband
    • Technical feasibility of Cardioband adjustment
    • Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure, at hospital discharge, and at 30 days.


Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Device: Cardioband
Other Name: With Transfemoral delivery system

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 ≤ 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01841554

Locations
France
Bichat hospital Recruiting
Paris, France, 18 75877
Contact: Alec Vahanian, MD    +33140256735/60      
Principal Investigator: Alec Vahanian, Prof         
Germany
Asklepios Klinik, St. Georg Not yet recruiting
Hamburg, Germany, 5 20099
Contact: Karl-Heinz Kuck, Prof         
Contact    +49401818852305      
Principal Investigator: Karl-Heinz Kuck, Prof         
Sponsors and Collaborators
Valtech Cardio Ltd
  More Information

No publications provided

Responsible Party: Valtech Cardio Ltd
ClinicalTrials.gov Identifier: NCT01841554     History of Changes
Other Study ID Numbers: CB1-2
Study First Received: April 23, 2013
Last Updated: April 23, 2013
Health Authority: France:ANSM

Keywords provided by Valtech Cardio Ltd:
Mitral Valve
Annuloplasty

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

ClinicalTrials.gov processed this record on April 17, 2014