Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Public ClinicalTrials.gov record NCT05069558. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective Randomized Multi-center Controlled Clinical Investigation Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05069558
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 450 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 9, 2022 (Actual)
- Primary completion
- Nov 30, 2025 (Actual)
- Completion
- Nov 2029 (Estimated)
- Last update posted
- Oct 16, 2026
2022 – 2029
United States locations
- U.S. sites
- 27
- U.S. states
- 18
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Cardiovascular Research Center | Phoenix | Arizona | 85016 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| Los Robles Medical Center | Thousand Oaks | California | 91360 | — |
| Colorado Heart and Vascular PC / St. Anthony Hospital | Lakewood | Colorado | 80228 | — |
| South Denver Cardiology Associates | Littleton | Colorado | 80120 | — |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| MaineHealth | Portland | Maine | 04102 | — |
| Tufts New England Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Essentia Health | Duluth | Minnesota | 55804 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| The Valley Hospital | Paramus | New Jersey | 07652 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | — |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | — |
| Vanderbilt Medical Center | Nashville | Tennessee | 37232 | — |
| HCA Houston Healthcare Medical Center | Houston | Texas | 77004 | — |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05069558, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05069558 live on ClinicalTrials.gov.