Clinical trial NCT03361007: Polish Registry of Common Carotid Artery Access for TAVI
Official title: Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Implantation Through Common Carotid Artery Access in Polish Population - Observational Multicenter Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Ventricular Outflow Obstruction, Left
Keywords: TAVI
common carotid artery
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Qualification for TAVI through common carotid artery by decision of the local Heart Team
* Patient provided written informed consent

Primary outcomes:
measure: VARC (Valve Academic Research Consortium-2) defined "Clinical Efficacy" composite endpoint
timeFrame: From 30 days post procedure to completion of at least 2 years of follow up
Secondary outcomes:
measure: VARC defined 'Device success' composite endpoint
timeFrame: 30 days
measure: VARC defined "Early Safety" composite endpoint
timeFrame: 30 days
measure: VARC defined "Time-related valve safety" composite endpoint
timeFrame: From device implant to completion of at least 2 years of follow up
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdansk
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Opole
country: Poland
facility: University of Opole
city: Poznań
country: Poland
facility: Poznan University of Medical Sciences
city: Warsaw
country: Poland
facility: Medical University of Warsaw
city: Łódź
country: Poland
facility: Medical University of Lodz
Study officials:
affiliation: Medical University of Warsaw
name: Zenon Huczek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Warsaw
name: Radosław Wilimski, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.