Polish Registry of Common Carotid Artery Access for TAVI (POL-CAROTID)

Medical University of Warsaw

Status: Enrolling

Conditions: Aortic Valve Stenosis; Ventricular Outflow Obstruction, Left

Treatments: Device: Transcatheter Aortic Valve Implantation (TAVI)

Study type: Observational

Funder types: Other

Identifiers

NCT03361007

WUM-CCA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

200 participants in 1 patient group

Common carotid artery access for TAVI

Description:

Patients in whom femoral artery could not be used to deliver the bioprosthesis for any reason.

Treatment:

Device: Transcatheter Aortic Valve Implantation (TAVI)