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

May 24, 2010
February 7, 2012
March 2010
February 2012   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01137734 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation
Valtech Cardinal Adjustable Semi-Rigid Annuloplasty Ring System For Treatment of Mitral Valve Regurgitation in Open Surgical Repair

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mitral Valve Insufficiency
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
August 2013
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Belgium
 
NCT01137734
VC1-1
Yes
Nitza Shoham, PhD, Valtech Cardio Ltd
Valtech Cardio Ltd
Not Provided
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
Valtech Cardio Ltd
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP