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| Name | Class |
|---|---|
| King's College London | OTHER |
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
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The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
The objective of this study is to evaluate the long term safety and effectiveness of the CE-marked JenaValve System Transapical in an elderly patient population with severe aortic stenosis and/or aortic insufficiency who are at high risk for open surgical aortic valve replacement.
The target study population will consist of elderly patients suffering from severe symptomatic degenerative aortic valve stenosis and/or aortic insufficiency who show an increased risk for an open aortic valve replacement surgery due to existing co-morbidities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High risk patients with aortic stenosis | Transapical aortic valve implantation using a transcatheter heart valve for aortic stenosis. |
| |
| High risk patients with AI | Transapical aortic valve implantation using a transcatheter heart valve for aortic regurgitation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter aortic valve replacement | Device | Transcatheter aortic valve replacement via a transapical access |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 30-day mortality of procedure is defined as all deaths within 30 days after implantation of the JenaValve prosthesis irrespective of the underlying cause of death. | 30 day |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints |
|
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Inclusion Criteria:
Exclusion Criteria:
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Patients with severe aortic stenosis or with severe aortic insufficiency and an increased risk for an open aortic valve replacement surgery
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| Name | Affiliation | Role |
|---|---|---|
| Olaf Wendler, Prof | King's College Hospital NHS Trust | Principal Investigator |
| Hendrik Treede, Prof | University Heart Center Hamburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz- und Diabeteszentrum NRW | Bad Oeynhausen | Germany | ||||
| Herzzentrum der Universität |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26346128 | Background | Mieres J, Menendez M, Fernandez-Pereira C, Rubio M, Rodriguez AE. Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk. Case Rep Cardiol. 2015;2015:458151. doi: 10.1155/2015/458151. Epub 2015 Aug 4. | |
| 25129672 | Background | Seiffert M, Bader R, Kappert U, Rastan A, Krapf S, Bleiziffer S, Hofmann S, Arnold M, Kallenbach K, Conradi L, Schlingloff F, Wilbring M, Schafer U, Diemert P, Treede H. Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation. JACC Cardiovasc Interv. 2014 Oct;7(10):1168-74. doi: 10.1016/j.jcin.2014.05.014. Epub 2014 Aug 13. |
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|
| peri- and post-operatively and at 3, 6, 12, 24 and 36 months |
| Device Success | The following parameters will be collected to assess device success:
| Index Procedure and Immediate Post-operative |
| Device Effectiveness | The following parameters will assess effectiveness:
| Prior to discharge, at 3, 6, 12, 24 and 36 months |
| SF-12 Survey of Quality of Life | The SF-12 health survey to measure mental and physical health of the patient. | at 12 months |
| Combined Safety Endpoint | A combined safety endpoint will be assessed at 30 days consisting of the following variables:
| at 30 days |
| Combined Efficacy Endpoint | A combined efficacy endpoint will be assessed consisting of the following variables:
| at 12 months |
| Cologne |
| Germany |
| Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden | Dresden | Germany |
| University Hospital | Erlangen | Germany |
| University Heart Centre | Freiburg im Breisgau | Germany |
| Asklepios Klinik | Hamburg | Germany |
| Universitäres Herzzentrum Hamburg | Hamburg | Germany |
| Herzzentrum Leipzig - Universitätsklinik | Leipzig | Germany |
| Deutsches Herzzentrum München | Munich | Germany |
| Herzzentrum des Städtischen Klinikums München | Munich | Germany |
| Herz- und Kreislaufzentrum Rotenburg (Fulda) | Rotenburg an der Fulda | Germany |
| Robert Bosch Krankenhaus Stuttgart | Stuttgart | Germany |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands |
| Universitätsspital Basel | Basel | Switzerland |
| King's College Hospital | London | United Kingdom |
| 27242354 | Result | Silaschi M, Treede H, Rastan AJ, Baumbach H, Beyersdorf F, Kappert U, Eichinger W, Ruter F, de Kroon TL, Lange R, Ensminger S, Wendler O. The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis. Eur J Cardiothorac Surg. 2016 Nov;50(5):874-881. doi: 10.1093/ejcts/ezw170. Epub 2016 May 30. |
| 29171730 | Result | Silaschi M, Conradi L, Wendler O, Schlingloff F, Kappert U, Rastan AJ, Baumbach H, Holzhey D, Eichinger W, Bader R, Treede H. The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation. Catheter Cardiovasc Interv. 2018 Jun;91(7):1345-1351. doi: 10.1002/ccd.27370. Epub 2017 Nov 24. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
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