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In the past years a substantial shift away from mechanical heart valves occurred and bioprosthetic heart valves claimed majority of market shares irrespective of patients' age.This indicates that population with failed surgical bioprostheses requiring ViV-TAVI will grow significantly and therefore, meticulous prospective data collection is necessary for future analyses in order to better understand potential limitations of this procedure.
The study is a prospective multicenter evaluation of transcatheter aortic valve-in-valve implantations in Polish health centers.
Duration of this study is expected to be 6 years to ensure that all of the enrolled patients will complete at least 2 years of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter Aortic Valve-in-Valve Implantation Cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI) | Device | Patients with failed aortic valve bioprostheses qualified for TAVI due to coexisting illnesses |
|
| Measure | Description | Time Frame |
|---|---|---|
| VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint |
| From 30 days post procedure to completion of at least 2 years of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| VARC defined 'Device success' composite endpoint |
| 30 days |
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Inclusion Criteria:
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All patients meeting inclusion criteria will prospectively included in the study. Patients meeting inclusion criteria before the set-up of registry will be included retrospectively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kajetan Grodecki | Contact | +48660675782 | kajetan.grodecki@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zenon Huczek, MD, PhD | Medical University of Warsaw | Principal Investigator |
| Wojciech Wojakowski, MD, PhD | Medical University of Silesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Bialystok | Recruiting | Bialystok | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23026738 | Background | Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium (VARC)-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60. doi: 10.1093/ejcts/ezs533. Epub 2012 Oct 1. | |
| 26994123 |
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|
| VARC defined "Early Safety" composite endpoint |
| 30 days |
| VARC defined "Time-related valve safety" composite endpoint |
| From device implant to completion of at least 2 years of follow up |
| Polish-American Heart Clinic | Recruiting | Bielsko-Biala | Poland |
|
| Medical University of Gdansk | Recruiting | Gdansk | Poland |
|
| Medical University of Silesia | Recruiting | Katowice | Poland |
|
| Jagiellonian University Medical College | Recruiting | Krakow | Poland |
|
| Medical University of Lodz | Recruiting | Lodz | Poland |
|
| Poznan University of Medical Sciences | Recruiting | Poznan | Poland |
|
| District Hospital 2 | Recruiting | Rzeszów | Poland |
|
| Institute of Cardiology | Recruiting | Warsaw | Poland |
|
| Medical University of Warsaw | Recruiting | Warsaw | Poland |
|
| Wroclaw Medical University | Recruiting | Wroclaw | Poland |
|
| Silesian Center for Heart Diseases | Recruiting | Zabrze | Poland |
|
| Background |
| McElhinney DB, Cabalka AK, Aboulhosn JA, Eicken A, Boudjemline Y, Schubert S, Himbert D, Asnes JD, Salizzoni S, Bocks ML, Cheatham JP, Momenah TS, Kim DW, Schranz D, Meadows J, Thomson JD, Goldstein BH, Crittendon I 3rd, Fagan TE, Webb JG, Horlick E, Delaney JW, Jones TK, Shahanavaz S, Moretti C, Hainstock MR, Kenny DP, Berger F, Rihal CS, Dvir D; Valve-in-Valve International Database (VIVID) Registry. Transcatheter Tricuspid Valve-in-Valve Implantation for the Treatment of Dysfunctional Surgical Bioprosthetic Valves: An International, Multicenter Registry Study. Circulation. 2016 Apr 19;133(16):1582-93. doi: 10.1161/CIRCULATIONAHA.115.019353. Epub 2016 Mar 18. |
| 30009390 | Result | Huczek Z, Grodecki K, Scislo P, Wilczek K, Jagielak D, Fil W, Kubler P, Olszowka P, Dabrowski M, Frank M, Grygier M, Kidawa M, Wilimski R, Zelazowska K, Witkowski A, Kochman J, Zembala M, Opolski G, Dvir D, Wojakowski W. Transcatheter aortic valve-in-valve implantation in failed stentless bioprostheses. J Interv Cardiol. 2018 Dec;31(6):861-869. doi: 10.1111/joic.12540. Epub 2018 Jul 15. |
| 30603033 | Result | Scislo P, Grodecki K, Binczak D, Kochman J, Wilimski R, Huczek Z. Valve-in-valve treatment of dysfunctional aortic bioprostheses - single-centre experience. Postepy Kardiol Interwencyjnej. 2018;14(4):425-428. doi: 10.5114/aic.2018.79872. Epub 2018 Dec 11. No abstract available. |
| 41303113 | Derived | Jonik S, Mazurek M, Rymuza B, Jankowski J, Dabrowski M, Wolny R, Chodor P, Wilczek K, Fil W, Milewski K, Protasiewicz M, Sciborski K, Kaplon-Cieslicka A, Skrobucha A, Hawranek M, Scislo P, Wilimski R, Kochman J, Grabowski M, Grygier M, Witkowski A, Huczek Z. Redo-Transcatheter Aortic Valve Implantation (Redo-TAVI)-Pilot Study from Multicentre Nationwide Registry. J Clin Med. 2025 Nov 14;14(22):8078. doi: 10.3390/jcm14228078. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| D000092242 | Ventricular Outflow Obstruction, Left |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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