NCT03309332

AMPLATZER PFO Occluder Post Approval Study

OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,214 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.

Detailed description

A maximum of 1214 adult subjects will be enrolled at up to 100 centers in the U.S. and Canada. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant.

Conditions

• Stroke
• Patent Foramen Ovale

Interventions

Type	Name	Description
DEVICE	AMPLATZER™ PFO Occluder	Implantation of the AMPLATZER™ PFO Occluder in the PFO

Timeline

• Start date: 2018-01-31
• Primary completion: 2030-02-05
• Completion: 2030-02-05
• First posted: 2017-10-13
• Last updated: 2026-03-11

Locations

88 sites across 7 countries: United States, Canada, Germany, Italy, Portugal, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study