Aortic Valve Stenosis Clinical Trial
— POL-CAROTIDOfficial title:
Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Implantation Through Common Carotid Artery Access in Polish Population - Observational Multicenter Registry
NCT number | NCT03361007 |
Other study ID # | WUM-CCA |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | May 30, 2024 |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | May 30, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Qualification for TAVI through common carotid artery by decision of the local Heart Team - Patient provided written informed consent |
Country | Name | City | State |
---|---|---|---|
Poland | Medical University of Gdansk | Gdansk | |
Poland | Medical University of Silesia | Katowice | |
Poland | Medical University of Lodz | Lódz | |
Poland | University of Opole | Opole | |
Poland | Poznan University of Medical Sciences | Poznan | |
Poland | Medical University of Warsaw | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw |
Poland,
Azmoun A, Amabile N, Ramadan R, Ghostine S, Caussin C, Fradi S, Raoux F, Brenot P, Nottin R, Deleuze P. Transcatheter aortic valve implantation through carotid artery access under local anaesthesia. Eur J Cardiothorac Surg. 2014 Oct;46(4):693-8; discussion 698. doi: 10.1093/ejcts/ezt619. Epub 2014 Jan 14. — View Citation
Huczek Z, Wilimski R, Kochman J, Szczudlik P, Scislo P, Rymuza B, Kaplon-Cieslicka A, Kolasa A, Marchel M, Filipiak KJ, Cichon R, Opolski G. Common carotid artery access for transcatheter aortic valve implantation. Kardiol Pol. 2015;73(7):478-84. doi: 10.5603/KP.2015.0122. — View Citation
Schirmer J, Conradi L, Seiffert M, Koschyk D, Blankenberg S, Reichenspurner H, Diemert P, Treede H. Transcatheter aortic valve implantation: alternative access options. Minerva Cardioangiol. 2013 Aug;61(4):429-35. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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