NCT01137734

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

May 24, 2010

Last Update Submit

October 29, 2021

Conditions

Mitral Valve Insufficiency

Keywords

Heart DiseasesHeart Valve DiseasesCardiovascular Diseases

Outcome Measures

Primary Outcomes (5)

  • 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.

    Day of surgery

  • 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.

    Day of surgery

  • 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.

    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

    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

    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 Outcomes (1)

  • Subject's Device Related Adverse Event Rate

    6 months

Study Arms (1)

Valtech Cardinal Mitral Annuloplasty Ring

EXPERIMENTAL

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

Interventions

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.

Also known as: Valtech Cardinal Adjustable ring
Valtech Cardinal Mitral Annuloplasty 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.

Valtech Cardinal Mitral Annuloplasty Ring

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hugo Vanermen

Aalst, B-9300, Belgium

Location

Hospital San Raffaele

Milan, 20132, Italy

Location

Related Publications (4)

  • 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.

    PMID: 32619617BACKGROUND

  • 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.

    PMID: 26371453BACKGROUND

  • 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.

    PMID: 25887519BACKGROUND

  • 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.

    PMID: 23530026BACKGROUND

MeSH Terms

Conditions

Mitral Valve InsufficiencyHeart DiseasesHeart Valve DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2010

First Posted

June 4, 2010

Study Start

March 1, 2010

Primary Completion

February 1, 2012

Study Completion

January 1, 2014

Last Updated

November 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be available to other researchers.

Locations

IT(1)BE(1)