An observational study in Aortic Valve Stenosis and Ventricular Outflow Obstruction, Left, sponsored by Medical University of Warsaw. Status unknown at 6 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by Medical University of Warsaw · Observational
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.
All patients meeting inclusion criteria will prospectively included in the study. Patients meeting inclusion criteria before the set-up of registry will be included retrospectively.
Inclusion Criteria:
Patients in whom femoral artery could not be used to deliver the bioprosthesis for any reason.
Device: Transcatheter Aortic Valve Implantation (TAVI)
Patients who were disqualified from surgical cortical valve replacement by decision of the Heart Team.
Also known as: Transcatheter Aortic Valve Replacement (TAVR)
VARC (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)
Time frame: From device implant to completion of at least 2 years of follow up
Plan to share: No
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of Warsaw