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Completed

NCT Number: NCT01137734

CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

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.

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Key information

Conditions

Mitral Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hugo Vanermen, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adjustable Annuloplasty Ring with option to adjust off pump.

Device

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 repair, 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 names: Valtech Cardinal Adjustable ring

Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)

Device

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.

Primary outcomes

  1. Percentage of Subjects with Valtech Cardinal Mitral Heart Valve Device Technical Success

    Time frame: Day of surgery

    Technical success of the implantation of the Cardinal Ring defined as the ability to size the annulus, place the sutures on the ring, lower the ring onto the valve, adjust the ring to the required size and disconnect the adjustment tool.

  2. Percentage of Subjects with Successful Off Pump Adjustment of their Valtech Cardinal Mitral Annuloplasty Ring

    Time frame: Day of surgery

    The technical feasibility of "off cardiac bypass pump" adjustment during surgery, when required of the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.

  3. Subject's Mitral Valve Regurgitation (MR) Post-procedure as Compared to Baseline

    Time frame: At the end of the procedure on the day of surgery compared to baseline.

    The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at the end of the procedure with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.

  4. Subject's Mitral Valve Regurgitation (MR) at Discharge as Compared to Baseline

    Time frame: Day of discharge compared to baseline.

    The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at hospital discharge with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.

  5. Subject's Mitral Valve Regurgitation (MR) at 30 Days as Compared to Baseline

    Time frame: 30 days compared to baseline.

    The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at 30 days with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.

Secondary outcomes

  1. Subject's Device Related Adverse Event Rate

    Time frame: 6 months

    The percentage of subjects that had a device related adverse event with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

Valtech Cardinal Adjustable Semi-Rigid Annuloplasty Ring System For Treatment of Mitral Valve Regurgitation in Open Surgical Repair

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Jun 4, 2010
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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