NCT04926142

Brief Summary

This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen ovale for cryptogenic stroke.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

July 5, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

4.1 years

First QC Date

June 11, 2021

Last Update Submit

January 31, 2024

Conditions

Patent Foramen OvaleAtrial FibrillationStroke

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation

    Occurrence of documented atrial fibrillation (i.e. at least one episode lasting 30 seconds)

    Within 2 months after percutaneous PFO closure

Secondary Outcomes (6)

  • Atrial fibrillation

    Within 24 months after percutaneous PFO closure

  • Burden of atrial fibrillation

    Within 2 years after percutaneous PFO closure

  • Relation between MR proANP levels and atrial fibrillation

    Within 2 years after percutaneous PFO closure

  • Stroke

    Within 2 years after percutaneous PFO closure

  • Peripheral emboli

    Within 2 years after percutaneous PFO closure

  • +1 more secondary outcomes

Study Arms (1)

Patients planned for percutaneous PFO closure

Patients will undergo implantation of a Holter device (Reveal Linq Medtronic) 2 months prior to percutaneous PFO closure. Devices will be monitored by telemonitoring until the PFO closure procedure, and at 2, 12 and 24 months after the procedure.

Device: Implantation of Holter deviceProcedure: Percutaneous PFO closure

Interventions

Implantation of Holter deviceDEVICE

Implantation of a Holter device (Reveal Linq, Medtronic) for telemonitoring of cardiac rhythm

Patients planned for percutaneous PFO closure
Percutaneous PFO closurePROCEDURE

Patients will undergo percutaneous closure of patent foramen ovale

Patients planned for percutaneous PFO closure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective patients who have had cryptogenic stroke (ischemic only) and with patent foramen ovale confirmed by transoesophageal echocardiography, with an indication for percutaneous closure.

You may qualify if:

  • Adult patients (aged \>18 years)
  • with an indication for percutaneous closure of PFO due to cryptogenic stroke, with indication validated by a cardio-neurological team.
  • patients must provide written informed consent
  • patients must be affiliated to a social security regime or be a beneficiary thereof.

You may not qualify if:

  • Patients under legal protection
  • Patients not affiliated to any social security regime

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital Besancon

Besançon, 25000, France

Location

CHU Lyon - Hôpital Louis Pradel

Bron, France

Location

CHU Dijon

Dijon, France

Location

CHU Grenoble

Grenoble, France

Location

Related Publications (1)

  • Badoz M, Derimay F, Serzian G, Besutti M, Rioufol G, Frey P, Guenancia C, Ecarnot F, Meneveau N, Chopard R. Incidence of atrial fibrillation in cryptogenic stroke with patent foramen ovale closure: protocol for the prospective, observational PFO-AF study. BMJ Open. 2023 Sep 12;13(9):e074584. doi: 10.1136/bmjopen-2023-074584.

    PMID: 37699623DERIVED

MeSH Terms

Conditions

Foramen Ovale, PatentAtrial FibrillationStroke

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Marc Badoz, MD

    Centre Hospitalier Universitaire de Besancon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2021

First Posted

June 14, 2021

Study Start

July 5, 2021

Primary Completion

August 21, 2025

Study Completion

December 31, 2025

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

FR(4)