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This Study is designed to observe the clinical outcomes of patients requiring mitral repair that were treated with the CE certified Cardinal System.
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| Measure | Description | Time Frame |
|---|---|---|
| • Ability of the Cardinal ring to reduce mitral valve regurgitation | 30 day | |
| • Percentage of patients in whom the size of the ring is adjusted | 6 months | |
| • Technical feasibility of adjustment. | The ability of the surgeon to adjust the Cardinal ring when required, will be measured on a scale of 1-3 (1- successfull, 3- unsuccessful) | 6 months |
| • The occurrence of serious device related adverse events in all patients. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are candidate for mitral valve repair, with our without concomitant procedures.
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| Name | Affiliation | Role |
|---|---|---|
| Ottavio Alfieri, Prof, MD | Hospital San Raffaele, Milan, Italy | Principal Investigator |
| Nicolas Doll, Prof, MD | SANA Herzchirurgie Stuttgart , Germany | Principal Investigator |
| Ehud Raanani, Prof, MD | Sheba Medical Center | Principal Investigator |
| Patrik Nataf, Prof, MD | Bichat Hospital | Principal Investigator |
| Volkmar Falk, Prof, MD | Zurich University, Zurich, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SANA Herzchirurgie | Stuttgart | 70174 | Germany | |||
| Hospital San Rafaele |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28012074 | Background | Sundermann SH, Czesla M, Kempfert J, Walther T, Nataf P, Raanani E, Jacobs S, Alfieri O, Maisano F, Falk V. Results of mitral valve repair with an adjustable annuloplasty ring 2 years after implantation. Heart Vessels. 2017 Jul;32(7):843-849. doi: 10.1007/s00380-016-0934-7. Epub 2016 Dec 23. |
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Individual participant data will not be available to other researchers.
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Milan |
| 20132 |
| Italy |