NCT02987894

PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry

Prospective Observation of Aortic Regurgitation After TAVI and Progress Over Time: PROGRESS PVL Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Symetis SA · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.

Detailed description

The primary objective of this post-market registry is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and the ACURATE TF™ Transferral Delivery System in 500 consented patients with severe aortic stenosis and treated according to the instructions for use (IFU). Examinations to evaluate the aortic valve regurgitation performed as standard of care in patients undergoing transcatheter aortic valve replacement will be analyzed by an external Core Laboratory. These examinations are limited to echocardiography and/or contrast aortography assessments. The secondary objective is to collect adverse events and evaluate them according to the VARC-2 consensus document.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	ACURATE neo™ Aortic Bioprosthesis	TAVI, transcatheter aortic valve replacement. Transfemoral access.

Timeline

• Start date: 2017-01-02
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2016-12-09
• Last updated: 2020-04-09

Locations

23 sites across 4 countries: Canada, Germany, Italy, United Kingdom