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

2017-07-31 12:53:58 | BioPortfolio


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 Design


Foramen Ovale, Patent


Aspirin, Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder


Mayo Clinic in Rochester
United States


Not yet recruiting


Mayo Clinic

Results (where available)

View Results


Published on BioPortfolio: 2017-07-31T12:53:58-0400

Clinical Trials [1968 Associated Clinical Trials listed on BioPortfolio]

GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transfer...

GORE® CARDIOFORM Septal Occluder Migraine Clinical Study: A Study to Evaluate the Safety and Efficacy of Transcatheter Closure of Patent Foramen Ovale for Relief of Migraine Headaches

Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief

Electromagnetic Interference and Automobile Remote Keyless Entry in Cardiovascular Implantable Electronic Device (CIED) Patients

Cardiovascular Implantable Electronic device (CIED) is a evolution therapy and number of patients with it are growing rapidly. Electromagnetic interference causing device malfunction is no...

GORE® HELEX® Septal Occluder / GORE® Septal Occluder for Patent Foramen Ovale (PFO) Closure in Stroke Patients - The Gore REDUCE Clinical Study

The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder / GORE® Septal Occluder plus antiplatelet medical management is safe an...

Long-term Safety Study of the GORE HELEX(tm) Septal Occluder

The purpose of this study is to evaluate the long-term safety and efficacy of the GORE HELEX(tm) Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).

PubMed Articles [6893 Associated PubMed Articles listed on BioPortfolio]

Effect of fibrotic capsule debridement during generator replacement on cardiac implantable electronic device infection risk.

Cardiovascular implantable electronic device (CIED) replacement is increasingly common. It has been proposed that capsule removal at the time of CIED replacement may reduce infection rates. In this st...

Thrombocytopenia and End Stage Renal Disease are Key Predictors of Survival in Patients with Cardiac Implantable Electronic Device Infections.

Cardiac implantable electronic device (CIED) infections are associated with a high mortality. Our aim was to identify key predictors of survival in patients with CIED infections as to be able to detec...

Bundled skin antiseptic preparation for complex cardiac implantable electronic device infection - a propensity score matching cohort study.

Cardiac implantable electronic device (CIED) infection, a major complication of a CIED implant procedure, can prolong hospitalization and cause mortality.

Two cases of pericardial tamponade due to nitinol wire fracture of a gore septal occluder.

Percutaneous patent foramen ovale (PFO) closure is recommended for secondary prevention of paradoxical embolism through a PFO. In the United States, two Food and Drug Administration-approved PFO closu...

Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads: Data From the TriValve Registry.

The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific ...

Medical and Biotech [MESH] Definitions

A CATHETER-delivered implant used for closing abnormal holes in the cardiovascular system, especially HEART SEPTAL DEFECTS; or passageways intentionally made during cardiovascular surgical procedures.

A non-steroidal anti-inflammatory agent that is less effective than equal doses of ASPIRIN in relieving pain and reducing fever. However, individuals who are hypersensitive to ASPIRIN may tolerate sodium salicylate. In general, this salicylate produces the same adverse reactions as ASPIRIN, but there is less occult gastrointestinal bleeding. (From AMA Drug Evaluations Annual, 1992, p120)

Asthmatic adverse reaction (e.g., BRONCHOCONSTRICTION) to conventional NSAIDS including aspirin use.

Gray matter structures of the telencephalon and limbic system in the brain, but containing widely varying definitions among authors. Included here is the cortical septal area, subcortical SEPTAL NUCLEI, and the SEPTUM PELLUCIDUM. Many authorities consider the septal region to be made up of the septal area and the septal nuclei, but excluding the septum pellucidum. (Anthoney, Neuroanatomy and the Neurologic Exam, 1994, pp485-489; NeuroNames, (November 18, 1998)).

A drug combination of aspirin and dipyridamole that functions as a PLATELET AGGREGATION INHIBITOR, used to prevent THROMBOSIS and STROKE in TRANSIENT ISCHEMIC ATTACK patients.

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