Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI) Registry
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Transcatheter Aortic Valve-in-Valve Implantation Cohort
|
Device: Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)
Patients with failed aortic valve bioprostheses qualified for TAVI due to coexisting illnesses
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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]
All-cause mortality All stroke (disabling and non-disabling) Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure NYHA (New York Heart Association) class III or IV functional classification of heart failure Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, Effective Orifice Area (EOA) ≤0.9-1.1 cm2(c) and/or Doppler Velocity Integral (DVI) <0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation
Secondary Outcome Measures
- VARC defined 'Device success' composite endpoint [30 days]
Absence of procedural mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis - patient mismatch and mean aortic valve gradient ,20 mmHg or peak velocity ,3 m/s, AND no moderate or severe prosthetic valve regurgitation)
- VARC defined "Early Safety" composite endpoint [30 days]
All-cause mortality All stroke (disabling and non-disabling) Life-threatening bleeding Acute kidney injury-Stage 2 or 3 (including renal replacement therapy) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure (Balloon Aortic Valvuloplasty (BAV), Trans Catheter Aortic Valve Implant (TAVI), or Surgical Aortic Valve Replacement (SAVR))
- VARC defined "Time-related valve safety" composite endpoint [From device implant to completion of at least 2 years of follow up]
Structural valve deterioration Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm2cand/or DVI <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation) Requiring repeat procedure (TAVI or SAVR) Prosthetic valve endocarditis Prosthetic valve thrombosis Thrombo-embolic events (e.g. stroke) VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Failing surgically implanted aortic bioprosthetic valve (stented/stentless/homograft) demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
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Qualification for TAVI by decision of the local Heart Team
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Patient provided written informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Bialystok | Białystok | Poland | ||
| 2 | Polish-American Heart Clinic | Bielsko-Biala | Poland | ||
| 3 | Medical University of Gdansk | Gdańsk | Poland | ||
| 4 | Medical University of Silesia | Katowice | Poland | ||
| 5 | Jagiellonian University Medical College | Kraków | Poland | ||
| 6 | Poznan University of Medical Sciences | Poznań | Poland | ||
| 7 | District Hospital 2 | Rzeszów | Poland | ||
| 8 | Institute of Cardiology | Warsaw | Poland | ||
| 9 | Medical University of Warsaw | Warsaw | Poland | ||
| 10 | Wroclaw Medical University | Wrocław | Poland | ||
| 11 | Silesian Center for Heart Diseases | Zabrze | Poland | ||
| 12 | Medical University of Lodz | Łódź | Poland |
Sponsors and Collaborators
- Medical University of Warsaw
Investigators
- Principal Investigator: Zenon Huczek, MD, PhD, Medical University of Warsaw
- Principal Investigator: Wojciech Wojakowski, MD, PhD, Medical University of Silesia
Study Documents (Full-Text)
None provided.More Information
Publications
- Kappetein AP, Head SJ, Généreux 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, Rodés-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.
- 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.
- WUM-VIV