Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation
Public ClinicalTrials.gov record NCT03232450. 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
PFOCUS Pilot Trial- A Prospective Pilot Trial for PFO ClosUre at the Time of endovaScular Cardiac Electronic Device Implantation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Participants enrolled in this study will have been diagnosed with patent foramen ovale (PFO) and have been scheduled to have a cardiovascular implantable electronic device (CIED) such as a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implanted. A PFO is a condition when there is a hole in the septum (the wall separating the right and left sides) of the heart. The purpose of this study is to determine whether closing the PFO with the GORE® Cardioform Septal Occluder in people with an endocardial device leads reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) compared to not closing the PFO.
Study identification
- NCT ID
- NCT03232450
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- Not listed
Conditions and interventions
Conditions
Interventions
- Aspirin Drug
- Cardiovascular Implantable Device (CIED) Device
- Gore Cardioform Septal Occluder Device
Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- 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
- Jul 31, 2019
- Primary completion
- Nov 30, 2023
- Completion
- Nov 30, 2023
- Last update posted
- Mar 12, 2020
2019 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03232450, 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 Mar 12, 2020 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03232450 live on ClinicalTrials.gov.