CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

October 29, 2021 updated by: Edwards Lifesciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, B-9300
        • Hugo Vanermen
  • Italy
      • Milano, Italy, 20132
        • Hospital San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Valtech Cardinal Mitral Annuloplasty Ring
All subjects enrolled in the study are implanted with the Valtech Cardinal Mitral Annuloplasty ring.
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 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day of surgery
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.
Day of surgery
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.
At the end of the procedure on the day of surgery compared to baseline.
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.
Day of discharge compared to baseline.
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.
30 days compared to baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

May 24, 2010

First Submitted That Met QC Criteria

June 3, 2010

First Posted (ESTIMATE)

June 4, 2010

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VC1-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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