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Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation

NCT03232450 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-03-13

No results posted yet for this study

Summary

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.

Conditions

  • Foramen Ovale, Patent

Interventions

DRUG

Aspirin

Subjects will receive 81 mg enteric coated aspirin

DEVICE

Cardiovascular Implantable Device (CIED)

All subjects will receive either a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).

DEVICE

Gore Cardioform Septal Occluder

The Gore Cardioform Septal Occluder closes the patent foramen ovale (PFO).

Sponsors & Collaborators

Principal Investigators

  • Samuel J Asirvatham · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-31
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT03232450 on ClinicalTrials.gov