Aortic Valve Insufficiency, Aortic Valve Stenosis, Ventricular Outflow Obstruction, Left
Conditions
Keywords
TAVI, valve-in-valve, aortic stenosis
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.
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.
Interventions
DEVICETranscatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)
Patients with failed aortic valve bioprostheses qualified for TAVI due to coexisting illnesses
Sponsors
Medical University of Warsaw
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Failing surgically implanted aortic bioprosthetic valve (stented/stentless/homograft) demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency * Qualification for TAVI by decision of the local Heart Team * Patient provided written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Poland
Contacts
Primary ContactKajetan Grodecki
Outcome results
None listed