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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Common carotid artery access for TAVI | Patients in whom femoral artery could not be used to deliver the bioprosthesis for any reason. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | Device | Patients who were disqualified from surgical cortical valve replacement by decision of the Heart Team. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| VARC defined 'Device success' composite endpoint |
| 30 days |
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Inclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kajetan Grodecki | Contact | +48660675782 | kajetan.grodecki@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zenon Huczek, MD, PhD | Medical University of Warsaw | Principal Investigator |
| Radosław Wilimski, MD | Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Gdansk | Recruiting | Gdansk | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26189468 | Background | 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. | |
| 24431170 | Background | 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. |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D000092242 | Ventricular Outflow Obstruction, Left |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| VARC defined "Early Safety" composite endpoint |
| 30 days |
| VARC defined "Time-related valve safety" composite endpoint |
| From device implant to completion of at least 2 years of follow up |
| Medical University of Silesia | Recruiting | Katowice | Poland |
|
| Medical University of Lodz | Recruiting | Lodz | Poland |
|
| University of Opole | Recruiting | Opole | Poland |
|
| Poznan University of Medical Sciences | Recruiting | Poznan | Poland |
|
| Medical University of Warsaw | Recruiting | Warsaw | Poland |
|
| 23846009 | Background | 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. |
| D014694 |
| Ventricular Outflow Obstruction |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |