CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

This study is ongoing, but not recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 24, 2010

Last Updated Date

February 7, 2012

Start Date ^ICMJE

March 2010

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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:

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01137734 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Mitral Valve Insufficiency

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Italy

Administrative Information

NCT Number ^ICMJE

NCT01137734

Other Study ID Numbers ^ICMJE

VC1-1

Has Data Monitoring Committee

Yes

Responsible Party

Nitza Shoham, PhD, Valtech Cardio Ltd

Study Sponsor ^ICMJE

Valtech Cardio Ltd

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Valtech Cardio Ltd

Verification Date

February 2012

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

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