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.
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.
Study Type
OBSERVATIONAL
Enrollment
200
Patients who were disqualified from surgical cortical valve replacement by decision of the Heart Team.
Medical University of Gdansk
Gdansk, Poland
RECRUITINGMedical University of Silesia
Katowice, Poland
RECRUITINGMedical University of Lodz
Lodz, 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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University of Opole
Opole, Poland
RECRUITINGPoznan University of Medical Sciences
Poznan, Poland
RECRUITINGMedical University of Warsaw
Warsaw, Poland
RECRUITINGTime frame: From device implant to completion of at least 2 years of follow up