Clinical trial NCT01137734: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Valve Insufficiency
Keywords: Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2010-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Subjects with Valtech Cardinal Mitral Heart Valve Device Technical Success
timeFrame: Day of surgery
measure: Percentage of Subjects with Successful Off Pump Adjustment of their Valtech Cardinal Mitral Annuloplasty Ring
timeFrame: Day of surgery
measure: Subject's Mitral Valve Regurgitation (MR) Post-procedure as Compared to Baseline
timeFrame: At the end of the procedure on the day of surgery compared to baseline.
measure: Subject's Mitral Valve Regurgitation (MR) at Discharge as Compared to Baseline
timeFrame: Day of discharge compared to baseline.
measure: Subject's Mitral Valve Regurgitation (MR) at 30 Days as Compared to Baseline
timeFrame: 30 days compared to baseline.
Secondary outcomes:
measure: Subject's Device Related Adverse Event Rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Hugo Vanermen
city: Milano
country: Italy
facility: Hospital San Raffaele
Study officials:
affiliation: Hospital Onze-Lieve-Vrouw-Ziekenhuis, Aalst , Belgium
name: Hugo Vanermen, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Leipzig, Germany
name: Fredrich Mohr, Prof,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Zurich, Switzerland
name: Volkmar Falk, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.