CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Valtech Cardio Ltd.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Valtech Cardio Ltd
ClinicalTrials.gov Identifier:
NCT01137734
First received: May 24, 2010
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

Annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty ring, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.


Condition Intervention Phase
Mitral Valve Insufficiency
Device: Adjustable Annuloplasty Ring with option to adjust off pump.
Device: Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Valtech Cardinal Adjustable Semi-Rigid Annuloplasty Ring System For Treatment of Mitral Valve Regurgitation in Open Surgical Repair

Resource links provided by NLM:


Further study details as provided by Valtech Cardio Ltd:

Primary Outcome Measures:
  • Performance and safety [ Time Frame: Number 1 and 2 procedure. Number 3. at 6 month ] [ Designated as safety issue: Yes ]

    Following are the primary endpoints:

    1. Technical Success Rate of the implantation
    2. Technical feasibility of "off pump" adjustment, when required, of the Valtech Cardinal Ring
    3. Reduction of mitral valve regurgitation (MR)


Secondary Outcome Measures:
  • safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Incidence of Major Adverse Events (MAE) equal or lower than that reported in the literature.


Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: August 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Adjustable Annuloplasty Ring with option to adjust off pump.
    Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty rean, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.
    Other Name: Valtech Cardinal Adjustable ring
    Device: Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)
    Evaluate the performance and safety of the investigational adjustable annuloplasty ring device for the treatment of mitral regurgitation, with option to adjust on and off-pump.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is a candidate for mitral valve repair.
  • Patient able and willing to return to the implant center for follow-up visits.
  • Able and willing to give informed consent and follow protocol procedures.

Exclusion Criteria:

  • Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
  • Evolving endocarditis or active endocarditis in the last 3 months.
  • Heavily calcified annulus or leaflets.
  • Congenital malformation with limited valvular tissue
  • Patient requires mitral valve replacement.
  • Previously implanted prosthetic mitral valve or annuloplasty ring/band.
  • Patient requires aortic or pulmonic valve replacement or repair.
  • Patient is pregnant (urine HCG test result positive) or lactating.
  • Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk.
  • Life expectancy of less than twelve months.
  • Patient 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: NCT01137734

Locations
Belgium
Hugo Vanermen
Aalst, Belgium, B-9300
Italy
Hospital San Raffaele
Milano, Italy, 20132
Sponsors and Collaborators
Valtech Cardio Ltd
Investigators
Principal Investigator: Hugo Vanermen, Prof, MD Hospital Onze-Lieve-Vrouw-Ziekenhuis, Aalst , Belgium
Principal Investigator: Fredrich Mohr, Prof ,MD University Leipzig, Germany
Principal Investigator: Volkmar Falk, Prof, MD University Zurich, Switzerland
  More Information

No publications provided

Responsible Party: Nitza Shoham, PhD, Valtech Cardio Ltd
ClinicalTrials.gov Identifier: NCT01137734     History of Changes
Other Study ID Numbers: VC1-1
Study First Received: May 24, 2010
Last Updated: February 7, 2012
Health Authority: Italy: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic

Keywords provided by Valtech Cardio Ltd:
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases

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

ClinicalTrials.gov processed this record on July 28, 2014