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

NCT ID: NCT03232450

Last Updated: 2020-03-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-31
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PFO Closure

Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder.

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: DRUG

Subjects will receive 81 mg enteric coated aspirin

Cardiovascular Implantable Device (CIED)

Intervention Type: DEVICE

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

Gore Cardioform Septal Occluder

Intervention Type: DEVICE

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

Control

Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED)

Group Type: OTHER

Aspirin

Intervention Type: DRUG

Subjects will receive 81 mg enteric coated aspirin

Cardiovascular Implantable Device (CIED)

Intervention Type: DEVICE

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

Interventions

Aspirin

Subjects will receive 81 mg enteric coated aspirin

Intervention Type: DRUG

Cardiovascular Implantable Device (CIED)

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

Intervention Type: DEVICE

Gore Cardioform Septal Occluder

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

Intervention Type: DEVICE

Other Intervention Names

Acetylsalicylic acid (ASA)

Eligibility Criteria

Inclusion Criteria

• A clinical indication for a transvenous pacemaker or defibrillator implantation,
• Must have a documented PFO determined from Transthoracic Echocardiogram (TTE) echocardiographic agitated saline contrast study that is determined to be feasible for transcatheter closure.
• The GORE® CARDIOFORM Septal Occluder should only be used in subjects whose vasculature is adequate to accommodate a 10 Fr delivery sheath (or 12 Fr delivery sheath when a guidewire is used).
• All subjects must be able to undergo standardized neurocognitive testing, and dementia/mental status examination screening.

Exclusion Criteria

• Subjects with a survival expectancy of less than one year.
• Subjects with an atrial septal defect or shunt that clinically requires closure for hemodynamic or other purposes.
• Absence of a clinical indication for a transvenous CIED system.
• Subjects with any clinical indication mandating anticoagulation.
• Subjects with previously placed CIED devices will be excluded.
• Unable to take anti-platelet medications such as aspirin or clopidogrel (Plavix).
• With anatomy where the GORE® CARDIOFORM Septal Occluder size or position would interfere with other intracardiac or intravascular structures, such as cardiac valves or pulmonary veins.
• With active endocarditis, or other infections producing bacteremia, or with known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement.
• With known intracardiac thrombi.
• Known pregnancy at the time of automated implantable cardioverter-defibrillator (AICD) implant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Samuel J. Asirvatham

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel J Asirvatham

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

14-005348

Identifier Type: -

Identifier Source: org_study_id