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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valtech Cardinal Mitral Annuloplasty Ring | Experimental | All subjects enrolled in the study are implanted with the Valtech Cardinal Mitral Annuloplasty ring. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hugo Vanermen | Aalst | B-9300 | Belgium | |||
| Hospital San Raffaele |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32619617 | Background | 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. | |
| 26371453 |
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Individual participant data will not be available to other researchers.
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D006331 | Heart Diseases |
| D006349 | Heart Valve Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. |
|
| Milan |
| 20132 |
| Italy |
| 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. |
| 25887519 | Background | 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. |
| 23530026 | Background | 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. |