NCT03361007

Polish Registry of Common Carotid Artery Access for TAVI

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis
• Ventricular Outflow Obstruction, Left

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve Implantation (TAVI)	Patients who were disqualified from surgical cortical valve replacement by decision of the Heart Team.

Timeline

• Start date: 2018-01-01
• Primary completion: 2023-12-31
• Completion: 2024-05-30
• First posted: 2017-12-04
• Last updated: 2020-10-22

Locations

6 sites across 1 country: Poland

Regulatory

• FDA-regulated device study