NCT05537753

Encore PFO Closure Device - The PerFOrm Trial

Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Encore Medical Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.

Detailed description

This is a prospective, multicenter, randomized clinical study to determine the safety and effectiveness of the Encore PFO closure device, which is indicated for percutaneous, transcatheter closure of a patent foramen ovale (PFO) in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

Conditions

• Patent Foramen Ovale
• Cryptogenic Stroke

Interventions

Type	Name	Description
DEVICE	Encore PFO closure device	The Encore PFO closure device comprises an implant component and a single-use delivery system.
DEVICE	FDA-approved PFO closure device	Chosen by the investigator

Timeline

• Start date: 2023-07-12
• Primary completion: 2026-04-01
• Completion: 2030-10-01
• First posted: 2022-09-13
• Last updated: 2024-09-19

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study