CARDINAL Adjustable Annuloplasty Ring System For Treatment of Mitral Regurgitation

Study Overview
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Brief Summary
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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.

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

Conditions
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Mitral Valve Insufficiency

Intervention / Treatment
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* Device: Adjustable Annuloplasty Ring with option to adjust off pump.
* Device: Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valtech Cardinal Mitral Annuloplasty Ring<br>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.<br>* 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.<br>* Other names: Valtech Cardinal Adjustable ring;Device: Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Diseases, Heart Valve Diseases, Cardiovascular Diseases