Polish Registry of Common Carotid Artery Access for TAVI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Implantation Through Common Carotid Artery Access in Polish Population - Observational Multicenter Registry

Conditions
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Aortic Valve Stenosis, Ventricular Outflow Obstruction, Left

Intervention / Treatment
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* Device: Transcatheter Aortic Valve Implantation (TAVI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Qualification for TAVI through common carotid artery by decision of the local Heart Team Patient provided written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Common carotid artery access for TAVI<br>Patients in whom femoral artery could not be used to deliver the bioprosthesis for any reason. | Device: Transcatheter Aortic Valve Implantation (TAVI)<br>* Patients who were disqualified from surgical cortical valve replacement by decision of the Heart Team.<br>* Other names: Transcatheter Aortic Valve Replacement (TAVR);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From 30 days post procedure to completion of at least 2 years of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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)) | 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) | From device implant to completion of at least 2 years of follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, common carotid artery