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| ID | Type | Description | Link |
|---|---|---|---|
| P02C320_JV06EFS_CIP | Other Identifier | JenaValve Technology Inc. | |
| CA-0002 EU | Other Identifier | JenaValve Technology Inc. | |
| CA-0002 Germany | Other Identifier | JenaValve Technology Inc. | |
| CA-0011 | Other Identifier | JenaValve Technology Inc. |
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To collect information about treatment for severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.
This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat severe aortic regurgitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Experimental | TAVR with JenaValve Pericardial Valve and Delivery System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JenaValve Pericardial TAVR System | Device | TAVR with JenaValve Pericardial Valve and Delivery System |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality at 30 days | All-Cause mortality within the first 30 days post index procedure | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Absence of procedural mortality | At 30 days |
| Peri-Procedural Myocardial Infarction | Peri-procedural and spontaneous myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin B. Leon, MD | New York-Presbyterian/ Columbia University Medical Center | Study Chair |
| Torsten P. Vahl, MD | New York-Presbyterian/ Columbia University Medical Center | Principal Investigator |
| Vinod H. Thourani, MD | Piedmont Healthcare | Principal Investigator |
| Stephan Baldus, MD | Herzzentrum der Universität zu Köln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| California Pacific Medical Center Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34556282 | Derived | Hamid N, Ranard LS, Khalique OK, Hahn RT, Nazif TM, George I, Ng V, Leon MB, Kodali SK, Vahl TP. Commissural Alignment After Transfemoral Transcatheter Aortic Valve Replacement With the JenaValve Trilogy System. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2079-2081. doi: 10.1016/j.jcin.2021.07.025. No abstract available. |
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| At ≤72hr after the index procedure |
| Stroke-Free Survival | Disabling or non-disabling stroke | At 30 days and 1 year |
| Bleeding & Vascular Complications | Major and minor bleeding | 30 days |
| San Francisco |
| California |
| 94109 |
| United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| New York-Presbyterian/ Columbia University Medical Center | New York | New York | 10032 | United States |
| Baylor Scott & White Research Institute | Dallas | Texas | 75201 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Kerckhoff-Klinik GmbH Bad Nauheim | Bad Nauheim | 61231 | Germany |
| Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen | Bad Oeynhausen | 32545 | Germany |
| Deutsches Herzzentrum Berlin | Berlin | 13353 | Germany |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| Herzzentrum der Universität zu Köln | Cologne | 50937 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | 60323 | Germany |
| Universitäres Herzzentrum Hamburg | Hamburg | 20246 | Germany |
| Leiden University Medical Center | Leiden | 2333 | Netherlands |
| St. Antonius Hospital | Nieuwegein | 3435 | Netherlands |
| Erasmus University Medical Center | Rotterdam | 3062 | Netherlands |
| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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