Aortic Valve Stenosis, Ventricular Outflow Obstruction, Left
Conditions
Keywords
TAVI, common carotid artery
Brief summary
Transcatheter aortic valve implantation (TAVI) is valuable treatment option for patients, who are at the high risk of surgical aortic valve replacement (AVR). Majority of procedures are performed through femoral arteries, however in some this access cannot be applied. Common carotid artery is one of the alternative routes of delivering the device in those patients. Established registry aims at collecting the data prospectively to assess outcomes of TAVI through common carotid artery.
Detailed description
The study is a prospective multicenter evaluation of transcatheter aortic valve implantations through common carotid artery 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
Patients who were disqualified from surgical cortical valve replacement by decision of the Heart Team.
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
* Qualification for TAVI through common carotid artery 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