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Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure

NCT05907694 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 714

Last updated 2026-03-27

No results posted yet for this study

Summary

Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Data in older patients is limited and since the population ages and stroke remains a major cause of death and morbidity, randomized clinical trials are needed to better assess the benefit of PFO closure in this elderly population. Therefore, this study proposal sought to determine the efficacy of PFO closure for the prevention of recurrent stroke in older patients with PFO and cryptogenic stroke.

Conditions

  • Patent Foramen Ovale
  • Cryptogenic Stroke
  • Older Patients
  • Medical Treatment
  • Recurrent Stroke

Interventions

PROCEDURE

Transcatheter PFO closure

Transcatheter PFO closure procedure will be performed according to the standards and experience of each participating center. Any approved PFO occluder device will be allowed in the study. Patients will also receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

DRUG

Optimal medical treatment

Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

Sponsors & Collaborators

  • Josep Rodes-Cabau

    lead OTHER

Principal Investigators

  • IUCPQ Rodes-Cabau, MD, PhD · Fondation IUCPQ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-18
Primary Completion
2027-10-01
Completion
2037-10-01

Countries

  • Canada

Study Locations

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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 NCT05907694 on ClinicalTrials.gov