The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective is to evaluate if patent foramen ovale (PFO) closure and antiplatelet medical management can reduce the risk of recurrent stroke or transient ischemic attack (TIA) when compared to antiplatelet medical management alone in elderly patients above 50 years of age with a PFO and a history of cryptogenic stroke or TIA.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism

NCT00166257

Embolism, Paradoxical Heart Septal Defects, Atrial

UNKNOWN PHASE4

Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale

NCT00207376

Atrial Septal Defect Patent Foramen Ovale

COMPLETED NA

GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients

NCT00738894

Stroke Transient Ischemic Attack

COMPLETED NA

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

NCT03232450

Foramen Ovale, Patent

WITHDRAWN NA

Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System

NCT00968032

Foramen Ovale, Patent Heart Catheterization Heart Septal Defects, Atrial

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Prior to birth the fetal heart has a connection between the two atrias of the heart. After labour this connection often closes. About 10-15 % these connections remains open. This phenomenon is called patent foramen ovale or PFO, and is in most cases unsymptomatic.

The prevalence of PFO in patients with crytogenic (without known causes) stroke is much higher (about 40%)than the general population (about 10%). This has led to the theory that the presence of PFO can lead to stroke, by the passage of emboli from the peripheral venous circulation through the PFO to the brain by right-to-left shunting of the blood.

There are no existing data from prospective randomized studies focusing on the effect of device closure PFO in patients with cryptogenic stroke. Some observational retrospective studies have shown a beneficial effect in the reduction of recurrent stoke in patients younger that 50 years with cryptogenic stroke when PFO has been closed with a percutaneous device closure(PCD). Some studies have reported an 0% to 3.4% annual recurrence rate of stroke or TIA in patients treated with PDC. The recurrence rate of stroke or TIA in patients with crytogenic stroke or TIA in ordinary antithrombotic treatment is about 5-15 %.

The primary objective of this study is to assess whether percutaneous device closure of patent foramen ovale is superior to conventional antithrombotic treatment in preventing stroke recurrence in elderly patients above 50 years of age.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patent Foramen Ovale PFO Stroke TIA

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Device closure of PFO

Device closure of PFO followed by 6 month treatment with clopidogrel 75 mg and 75 - 150 mg of aspirin daily followed by a life long treatment with dipyridamol 200 mg twice daily plus 75-150 mg aspirin daily

Group Type EXPERIMENTAL

Percutaneous device closure of patent foramen ovale

Intervention Type DEVICE

Percutaneous device closure of patent foramen ovale

Medical anticoagulative treatment

Life long treatment with dipyridamol 200 mg twice daily plus 75-150 mg aspirin daily

Group Type ACTIVE_COMPARATOR

Percutaneous device closure of patent foramen ovale

Intervention Type DEVICE

Percutaneous device closure of patent foramen ovale

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Percutaneous device closure of patent foramen ovale

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Stroke or TIA within 30 days
* Above 50 years of age

Exclusion Criteria

* Deceases og the esophagus
* Dementia
* Allergy to aspirin
* Risk of non-compliance
* Lacking ability to give written or oral consent
* Atrial Fibrillation
* Neurological deficit lasting less than 6 hours

Minimum Eligible Age

51 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No