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Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve with transapical and transseptal delivery systems in patients with degenerative or functional/ischemic mitral regurgitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Treatment with the CardiAQ-Edwards™ Transcatheter Mitral Valve (transapical or transseptal delivery) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve | Device | Replacement of the mitral valve through a transcatheter approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from major adverse cardiac and cerebrovascular events | MACCE; all-cause mortality, myocardial infarction, stroke, renal failure, and conversion to surgery per MVARC definitions | 30 days |
| Freedom from individual adverse events | % Freedom from individual adverse events | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| New York Heart Association (NYHA) functional class | Number of patients with improvement in NYHA class | 30 days, 3 months, 6 months, 12 months |
| Six minute walk test: | Increase in distance (m) from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Sondergaard | The Rigshospitalet, Copenhagen, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital, University of British Columbia | Vancouver | British Columbia | V6Z 1Y6 | Canada | ||
| St. Michael's Hospital |
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| 30 days, 3 months, 6 months, 12 months |
| Reduction in mitral regurgitation (MR) grade: | Number of patients with reduction in MR grade from baseline | 30 days, 3 months, 6 months, 12 months |
| Technical success | Technical success per MVARC criteria (%) | 30 days, 3 months, 6 months, 12 months |
| Device success | Device success per MVARC criteria (%) | 30 days, 3 months, 6 months, 12 months |
| Procedure success | Procedure success per MVARC criteria (%) | 30 days, 3 months, 6 months, 12 months |
| Patient success | Patient success per MVARC criteria (%) | 30 days, 3 months, 6 months, 12 months |
| Toronto |
| Ontario |
| M5B 1W8 |
| Canada |
| Centre Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Centre de recherche Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ) | Québec | G1V 4G5 | Canada |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Centre Hospitalier Régional Universitaire de Lille | Lille | 59000 | France |
| Kerckhoff-Klinik GmbH | Bad Nauheim | 61231 | Germany |
| Deutsche Herzzentrum Berlin | Berlin | 13353 | Germany |
| Herzzentrum der UniKlinik Köln | Cologne | 50937 | Germany |
| University Heart Centre | Hamburg | 20146 | Germany |
| Leipzig Herzzentrum | Leipzig | 04289 | Germany |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Universita di Roma Tor Vergata | Roma | 00133 | Italy |
| Erasmus Medical Centre | Rotterdam | 3015 CE | Netherlands |
| InselSpital Bern | Bern | 3010 | Switzerland |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D005764 | Gastroesophageal Reflux |
| D009362 | Neoplasm Metastasis |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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