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Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion

NCT05069558 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-05-22

No results posted yet for this study

Summary

The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE).

Conditions

  • Stroke
  • Patent Foramen Ovale
  • PFO

Interventions

DEVICE

Investigational PFO Closure Device

Occlutech Flex II PFO Closure Device

DEVICE

Standard of Care PFO Closure Device

Amplatzer PFO Occluder and Gore Cardioform PFO Occluder

Sponsors & Collaborators

  • Occlutech International AB

    lead INDUSTRY

Principal Investigators

  • David Thaler, MD, PhD, FAHA · Tufts Medical Center and Tufts University School of Medicine

  • Steven Yakubov, MD, FACC, MSCAI · OhioHealth Heart & Vascular

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2025-11-30
Completion
2029-11-30
FDA Device
Yes

Countries

  • United States
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05069558 on ClinicalTrials.gov