NCT04861805

Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System

A Two -Stage First in Human (FIH) Feasibility / Pivotal Study of the Vienna Aortic Valve SE System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 267 (estimated)
• Sponsor: P+F Products + Features GmbH · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single arm, multicenter study in an cohort of up to 267 patients (up to 100 Roll-ins and 167 patients implanted per protocol) symptomatic patients with severe aortic stenosis who will be followed up for up to 5 years.

Detailed description

The purpose of this trial is to determine the safety and effectiveness of the Vienna Aortic Valve SE System, a new self-expanding transcatheter heart valve, in patients with symptomatic severe aortic stenosis (SSAS). This is a prospective, single arm, multicenter study in an expanding cohort of symptomatic patients with severe aortic stenosis following the FIH feasibility study. The clinical investigation comprises 11 visits (V1 to V11). After implantation of the IMD at visit 2, safety and effectiveness assessment of the device will be performed at 30 days (V4), 3 months (V5), 6 months (V6), 1 year (V7) and every year thereafter up to 5 years post-implantation (V8 to V11). In summary, the clinical investigation for the individual patient will end after 5 years with a full clinical evaluation. The primary study endpoints for safety and effectiveness will be reached at 30-day follow-up timepoint. The clinical trial is completed after all 267 patients, that are not prematurely withdrawn, have completed their 5-year follow-up visit involving all specified assessments.

Conditions

• Symptomatic Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Vienna Aortic Valve SE System	Vienna Aortic Valve SE system for TAVI.

Timeline

• Start date: 2023-07-03
• Primary completion: 2025-10-01
• Completion: 2030-10-01
• First posted: 2021-04-27
• Last updated: 2025-06-29

Locations

31 sites across 8 countries: Argentina, Brazil, Chile, India, Lithuania, Portugal, Spain, Turkey (Türkiye)