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CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

Primary Purpose

Mitral Valve Insufficiency

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Adjustable Annuloplasty Ring with option to adjust off pump.

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

About this trial

This is an interventional treatment trial for Mitral Valve Insufficiency focused on measuring Heart Diseases, Heart Valve Diseases, Cardiovascular Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hugo Vanermen
Hospital San Raffaele

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Valtech Cardinal Mitral Annuloplasty Ring

Arm Description

All subjects enrolled in the study are implanted with the Valtech Cardinal Mitral Annuloplasty ring.

Outcomes

Primary Outcome Measures

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

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.

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

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

Subject's Mitral Valve Regurgitation (MR) Post-procedure as 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.

Subject's Mitral Valve Regurgitation (MR) at Discharge as 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.

Subject's Mitral Valve Regurgitation (MR) at 30 Days as 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 Outcome Measures

Subject's Device Related Adverse Event Rate

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

Full Information

NCT ID

NCT01137734

First Posted

May 24, 2010

Last Updated

October 29, 2021

Sponsor

Edwards Lifesciences

1. Study Identification

Unique Protocol Identification Number

NCT01137734

Brief Title

CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Valve Insufficiency

Keywords

Heart Diseases, Heart Valve Diseases, Cardiovascular Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Valtech Cardinal Mitral Annuloplasty Ring

Arm Type

Experimental

Arm Description

All subjects enrolled in the study are implanted with the Valtech Cardinal Mitral Annuloplasty ring.

Intervention Type

Device

Intervention Name(s)

Adjustable Annuloplasty Ring with option to adjust off pump.

Other Intervention Name(s)

Valtech Cardinal Adjustable ring

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

Day of surgery

Title

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

Description

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

Time Frame

Day of surgery

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

Day of discharge compared to baseline.

Title

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

Description

Time Frame

30 days compared to baseline.

Secondary Outcome Measure Information:

Title

Subject's Device Related Adverse Event Rate

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hugo Vanermen, Prof, MD

Organizational Affiliation

Hospital Onze-Lieve-Vrouw-Ziekenhuis, Aalst , Belgium

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fredrich Mohr, Prof,MD

Organizational Affiliation

University Leipzig, Germany

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Volkmar Falk, Prof, MD

Organizational Affiliation

University Zurich, Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hugo Vanermen

City

Aalst

ZIP/Postal Code

B-9300

Country

Belgium

Facility Name

Hospital San Raffaele

City

Milano

ZIP/Postal Code

20132

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual participant data will not be available to other researchers.

Citations:

PubMed Identifier

32619617

Citation

Si MS, Conte JV, Romano JC, Romano MA, Andersen ND, Gerdisch MW, Kupferschmid JP, Fiore AC, Bakhos M, Bonilla JJ, Burke JR, Rankin JS, Wei LM, Badhwar V, Turek JW. Unicuspid Aortic Valve Repair Using Geometric Ring Annuloplasty. Ann Thorac Surg. 2021 Apr;111(4):1359-1366. doi: 10.1016/j.athoracsur.2020.04.147. Epub 2020 Jun 30.

Results Reference

background

PubMed Identifier

26371453

Citation

Czesla M, Gotte J, Voth V, Doll N. Single-Center Experience With Adjustable Annuloplasty Ring in Degenerative Mitral Regurgitation. Innovations (Phila). 2015 Jul-Aug;10(4):248-51; discussion 251. doi: 10.1097/IMI.0000000000000186.

Results Reference

background

PubMed Identifier

25887519

Citation

Kolsut P, Juraszek A, Brzozowski P, Dabrowski M, Witkowski A, Rozanski J, Kusmierczyk M. Case report on successful 'bail out' aortic homograft implantation in a 81-year old woman with aortic ring rupture after double TAVI procedure. J Cardiothorac Surg. 2015 Mar 4;10:28. doi: 10.1186/s13019-015-0233-x.

Results Reference

background

PubMed Identifier

23530026

Citation

Maisano F, Falk V, Borger MA, Vanermen H, Alfieri O, Seeburger J, Jacobs S, Mack M, Mohr FW. Improving mitral valve coaptation with adjustable rings: outcomes from a European multicentre feasibility study with a new-generation adjustable annuloplasty ring system. Eur J Cardiothorac Surg. 2013 Nov;44(5):913-8. doi: 10.1093/ejcts/ezt128. Epub 2013 Mar 25.

Results Reference

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CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

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