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.
Study Type
OBSERVATIONAL
Enrollment
150
Patients with failed aortic valve bioprostheses qualified for TAVI due to coexisting illnesses
Medical University of Bialystok
Bialystok, Poland
RECRUITINGPolish-American Heart Clinic
Bielsko-Biala, Poland
RECRUITINGVARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint
* 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
Time frame: From 30 days post procedure to completion of at least 2 years of follow up
VARC defined 'Device success' composite endpoint
* 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)
Time frame: 30 days
VARC defined "Early Safety" composite endpoint
* 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))
Time frame: 30 days
VARC defined "Time-related valve safety" composite endpoint
* 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)
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Medical University of Gdansk
Gdansk, Poland
RECRUITINGMedical University of Silesia
Katowice, Poland
RECRUITINGJagiellonian University Medical College
Krakow, Poland
RECRUITINGMedical University of Lodz
Lodz, Poland
RECRUITINGPoznan University of Medical Sciences
Poznan, Poland
RECRUITINGDistrict Hospital 2
Rzeszów, Poland
RECRUITINGInstitute of Cardiology
Warsaw, Poland
RECRUITINGMedical University of Warsaw
Warsaw, Poland
RECRUITING...and 2 more locations
Time frame: From device implant to completion of at least 2 years of follow up