Patent Foramen Ovale Closure in Older Patients (PFO-Elderly)

February 10, 2022 updated by: Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Patent Foramen Ovale Closure in Older Patients: A Collaborative Multicenter Retrospective Study

  • Describe the baseline and procedural characteristics of older patients undergoing PFO closure due to cryptogenic embolism.
  • Assess the long-term follow-up of this cohort, focusing on neurological events and their origin, major cardiac outcomes, as well as survival rates and death origin.
  • Seek for predictors of neurological event recurrence after the procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In patients with cryptogenic stroke, up to 4 randomized trials and subsequent meta-analyses have recently shown a significant reduction in recurrent ischemic stroke events following percutaneous closure of patent foramen ovale (PFO) . All randomized trials but one excluded patients older than 60 years, and a mean patient age of about 50 years was reported in the single randomized trial including older patients. Thus, whereas PFO closure has been established as the new gold-standard therapy in young patients with cryptogenic stroke and PFO, there are no definite recommendations on the management of patients older than 60 years. Some studies have shown that older patients with cryptogenic stroke exhibit a much higher prevalence of PFO (compared with patients with stroke of known cause), similar to that in younger populations, but scarce data exist on acute and mid-term clinical outcomes of older patients undergoing PFO closure.

The investigators have recently reported the results of study comparing the long-term clinical outcomes of patients older (vs. younger) than 60 years in our centre. A total of 475 consecutive patients (90 older than 60 years) were included, and the main results can be summarized as follows: 1) older patients with cryptogenic embolism and PFO exhibited a higher burden of cardiovascular risk factors; 2) PFO closure was safe in older patients, with no differences in periprocedural complications compared with younger patients; 3) at long-term (median of 8 years) follow-up post-PFO closure, the global mortality rate was higher among older patients, but differences were driven by noncardiovascular mortality (mainly cancer), and 4) the rate of recurrent stroke/TIA was low (much lower than that predicted by the RoPE score), but there was a tendency toward a higher incidence of recurrent stroke/TIA among older patients, which appeared to be partially related to cardiovascular risk factor burden (no differences in recurrent ischemic event rate were observed after adjustment for baseline differences in cardiovascular risk factors between groups). The main limitation of this study was the relatively low number of patients older than 60 years, precluding an appropriate evaluation of the factors associated with poorer clinical outcomes in this population. Thus, the investigators are planning to confirm prior findings in a collaborative project including a much larger cohort of patients. Also, the results of this retrospective study would provide the rationale for a CIHR submission on a randomized trial targeting this group of patients.

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • CRIUCPQ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients older than 60 years who have experienced a previous paradoxical embolism of unknown origin and underwent transcatheter PFO closure.

Description

Inclusion Criteria:

  • Patients older than 60 years who have experienced a previous paradoxical embolism (stroke, transient ischaemic attack or peripheral embolism) of unknown origin and underwent transcatheter PFO closure.

Exclusion Criteria:

  • PFO closure indication other than paradoxical embolism (example: platypnea orthodeoxia syndrome).
  • Surgical PFO closure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Older patients with cryptogenic embolism and PFO closure
Data (clinical events at last follow-up) on patients older than 60 years who have experienced a previous paradoxical embolism of unknown origin and underwent transcatheter PFO closure will be collected.
Other: Clinical events at last follow-up
Clinical events (stroke, transient ischemic attack, peripheral embolism, deep venous thrombosis, atrial fibrillation, myocardial infarction, bleeding episode, death) at last follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of stroke
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Rate of transient ischemic attack
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Rate of peripheral embolism
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Rate of deep venous thrombosis
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Rate of atrial fibrillation
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Rate of myocardial infarction
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Rate of bleeding
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Rate of death
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Collaborators

Hospital Clinic of Barcelona
Montreal Heart Institute
St. Boniface Hospital
Toronto General Hospital
Ottawa Heart Institute
Hospital Clinico de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFO-Elderly

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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