NCT05002088

Portico Valve-in-Valve Retrospective Registry

Retrospective Assessment of the Portico Transcatheter Aortic Valve for Valve-in-Valve Use

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 71 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.

Detailed description

Two options currently exist to treat failed surgical aortic bioprostheses: transcatheter valve-in-valve implantation (ViV) or redo surgical aortic valve replacement (rAVR). The objective of this comprehensive data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.

Conditions

• Aortic Valve Stenosis
• Aortic Valve Failure
• Aortic Insufficiency
• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve Replacement	Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement

Timeline

• Start date: 2021-10-21
• Primary completion: 2023-12-29
• Completion: 2023-12-29
• First posted: 2021-08-12
• Last updated: 2025-02-28
• Results posted: 2025-02-28

Locations

7 sites across 4 countries: Australia, Denmark, Germany, United Kingdom

Regulatory

• FDA-regulated device study