Cardioband With Transfemoral Delivery System

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 July 24, 2014