clinical trial · NCT03309332
AMPLATZER PFO Occluder Post Approval Study
Abbott Medical Devices·N/A·active not recruiting·n = 1,214
StrokePatent Foramen OvaleAMPLATZER™ PFO Occluder
brief 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.
started
Jan 31, 2018
primary completion
Feb 5, 2030
completion
Feb 5, 2030
last updated
Mar 11, 2026
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.
official title
OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol