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| Name | Class |
|---|---|
| University of Giessen | OTHER |
| Heart Center Leipzig - University Hospital | OTHER |
| University Hospital Schleswig-Holstein | OTHER |
| Klinikum Links der Weser Bremen |
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Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-expandable valve under local anesthesia | Active Comparator | CoreValve Evolut R valve under local anesthesia with conscious sedation |
|
| Self-expandable valve under general anesthesia | Active Comparator | CoreValve Evolut R valve under general anesthesia |
|
| Balloon-expandable valve under local anesthesia | Active Comparator | Edwards Sapien 3 valve under local anesthesia with conscious sedation |
|
| Balloon-expandable valve under general anesthesia | Active Comparator | Edwards Sapien 3 valve under under general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoreValve Evolut R | Device |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (Device) | Number of participants with adverse events related to the treatment at 30-day follow-up consisting of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation | 30 day follow-up |
| Incidence of Treatment-Emergent Adverse Events (Anesthesia) | Number of participants with adverse events related to the treatment at 30-day follow-up consisting of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury | 30 day follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Luebeck | Lübeck | 23538 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36434335 | Derived | Stachel G, Abdel-Wahab M, de Waha-Thiele S, Desch S, Feistritzer HJ, Kitamura M, Farhan S, Eitel I, Kurz T, Thiele H. Fractal dimension of the aortic annulus: a novel predictor of paravalvular leak after transcatheter aortic valve implantation. Int J Cardiovasc Imaging. 2022 Nov;38(11):2469-2478. doi: 10.1007/s10554-022-02657-1. Epub 2022 Jun 24. | |
| 35942626 |
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| UNKNOWN |
| University Hopsital Schleswig Holstein Campus Lübeck | OTHER |
| Charite University, Berlin, Germany | OTHER |
| University of Rostock | OTHER |
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| Edwards Sapien 3 |
| Device |
|
| Local anesthesia with conscious sedation | Procedure |
|
| General anesthesia | Procedure |
|
| Farhan S, Stachel G, Desch S, Kurz T, Feistritzer HJ, Hartung P, Eitel I, Nef H, Doerr O, Lauten A, Landmesser U, Sandri M, Holzhey D, Borger M, Ince H, Oner A, Meyer-Saraei R, Wienbergen H, Fach A, Frey N, de Waha-Thiele S, Thiele H. Impact of moderate or severe left ventricular outflow tract calcification on clinical outcomes of patients with severe aortic stenosis undergoing transcatheter aortic valve implantation with self- and balloon-expandable valves: a post hoc analysis from the SOLVE-TAVI trial. EuroIntervention. 2022 Oct 21;18(9):759-768. doi: 10.4244/EIJ-D-22-00156. |
| 33926657 | Derived | Feistritzer HJ, Kurz T, Stachel G, Hartung P, Lurz P, Eitel I, Marquetand C, Nef H, Doerr O, Vigelius-Rauch U, Lauten A, Landmesser U, Treskatsch S, Abdel-Wahab M, Sandri M, Holzhey D, Borger M, Ender J, Ince H, Oner A, Meyer-Saraei R, Hambrecht R, Wienbergen H, Fach A, Augenstein T, Frey N, Konig IR, Vonthein R, Funkat AK, Berggreen AE, Heringlake M, Desch S, de Waha-Thiele S, Thiele H; SOLVE-TAVI Investigators. Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2021 May 4;77(17):2204-2215. doi: 10.1016/j.jacc.2021.03.007. |
| 32819145 | Derived | Thiele H, Kurz T, Feistritzer HJ, Stachel G, Hartung P, Lurz P, Eitel I, Marquetand C, Nef H, Doerr O, Vigelius-Rauch U, Lauten A, Landmesser U, Treskatsch S, Abdel-Wahab M, Sandri M, Holzhey D, Borger M, Ender J, Ince H, Oner A, Meyer-Saraei R, Hambrecht R, Fach A, Augenstein T, Frey N, Konig IR, Vonthein R, Ruckert Y, Funkat AK, Desch S, Berggreen AE, Heringlake M, de Waha-Thiele S; SOLVE-TAVI Investigators. General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial. Circulation. 2020 Oct 13;142(15):1437-1447. doi: 10.1161/CIRCULATIONAHA.120.046451. Epub 2020 Aug 21. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| 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 |
|---|---|
| D000772 | Anesthesia, Local |
| D016292 | Conscious Sedation |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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