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

NCT03232450 | Withdrawn FDA Device

• 1 other identifier: 14-005348
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Embolic Brain Lesions Detected on MRI >3 mm

  The mean number of embolic brain lesions will be calculated at approximately 1 year.

  1 year post implantation

Secondary Outcomes (6)

• Number of Subjects Who Die

  1 year post implantation

• Number of Subjects Who Experience a Stroke

  1 year post implantation

• Number of Subjects who Experience a Transient Ischemic Attack (TIA)

  1 year post implantation

• Change in Executive Function as Measured by Trail Making Test B

  baseline, 1 year post implantation

• Change in Language as Measured by Letter and Category Fluency Test

  baseline, 1 year post implantation

Study Arms (2)

PFO Closure

ACTIVE COMPARATOR

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

Drug: Aspirin; Device: Cardiovascular Implantable Device (CIED); Device: Gore Cardioform Septal Occluder

Control

OTHER

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

Drug: Aspirin; Device: Cardiovascular Implantable Device (CIED)

Interventions

Aspirin DRUG

Subjects will receive 81 mg enteric coated aspirin

Also known as: Acetylsalicylic acid (ASA)

Control; PFO Closure

Cardiovascular Implantable Device (CIED) DEVICE

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

Control; PFO Closure

Gore Cardioform Septal Occluder DEVICE

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

PFO Closure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Foramen Ovale, Patent

Interventions

Aspirin; Device Lead Extraction

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Device Removal; Surgical Procedures, Operative

Study Officials

• Samuel J Asirvatham

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 28, 2017
• Study Start: August 1, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)