StrokeAFEPFONCT04290052
Atrial Fibrillation After PFO Closure
An observational study of Stroke, run by University Hospital, Montpellier at 1 site in France.
Trial summary
An increased risk of atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized trials but systematic screening of AF was not performed in these studies. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stroke
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patient at least 18 years old, benefiting from percutaneous closure of the FOP after a cryptogenic stroke (indication validated during a multidisciplinary meeting with neurologists and cardiologists)
Who may be able to join
- Men or women over the age of 18 to 60
- Benefiting from the closure of the FOP percutaneously after a cryptogenic ischemic stroke or a TIA (indication validated during a multidisciplinary meeting with neurologists and cardiologists)
Who cannot join
- Inability to perform a 24h ECG Holter
- Pregnant or lactating women
- Vulnerable people
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atrial Fibrillation on Holter Monitoring After Percutaneous Patent Foramen Ovale Closure : a Prospective Observational Study
An increased risk of atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized trials but systematic screening of AF was not performed in these studies. Purpose: The objective of this study was to evaluate incidence of AF in patients who underwent percutaneous PFO closure with serial 24-hours ambulatory ECG (AECG) monitoring during 6 months follow-up. Primary endpoint was incidence of AF on ECG monitoring. Secondary endpoints were clinical outcomes (symptoms, hospitalization from cardiovascular causes, ischemic stroke, or bleeding) up to 6 month follow-up.
Read the detailed description
This is a prospective, bicentric, observational cohort study which will be performed in University hospital center of Montpellier and Nîmes The study will include all consecutive patients, admitted for a percutaneous PFO closure after an ischemic stroke (IS) or a transient ischemic attack (TIA) of cryptogenic origin, or after the occurrence of a decompression illness during scuba diving. Patients eligible for the closure of a FOP in prevention of the recurrence of stroke or TIA of cryptogenic origin, was systematically evaluated for exclusion of supraventricular arrhythmia in accordance with international recommendations. This evaluation included a 12-lead ECG as well as an extended electrocardiographic monitoring lasting more than or equal to 24 hours (most frequently, performing a 72-hour ECG Holter). All patients previously has a transesophageal ultrasound (TEE) allowing to retain the diagnosis of PFO, to assess the presence or not of an atrial septum aneurysm (ASA) associated with PFO and to quantify the right to left shunt thanks to a contrast test potentiated by a Valsalva maneuver. Exclusion criteria included interatrial defect with left to right and others indications for PFO closure that cryptogenic stroke or decompression illness. Indication of PFO closure is always validated by a cardio neurological team.
The primary objective of the study was incidence of AF defined as an irregular rhythm without discernible P waves lasting at least 30 seconds on ECG monitoring during the 6-month follow-up. The secondary objectives were to evaluate the characteristics of the supra-ventricular arrhythmias (delay in onset, duration, recurrent nature), incidence of others arrhythmia, symptoms, and prognostic implications of AF (hospitalization , need of curative anticoagulation, need for cardioversion and occurrence of neurological accident documented by imagery (ischemic stroke or TIA). The investigators also evaluated risk factors for occurrence of arrhythmia.
A total of 100 patients included during 1 year is expected
- Conditions
- Stroke
- Keywords
- Cryptogenic
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of sustained supra-ventricular arrhythmia
occurrence of sustained supra-ventricular arrhythmia (AF, atrial flutter) during the analysis the 24-hour Holter ECG performed post-intervention
Measured: the 24-hour post-intervention
occurrence of sustained supra-ventricular arrhythmia
occurrence of sustained supra-ventricular arrhythmia (AF, atrial flutter) during the analysis at 1 month (Holter ECG)
Measured: at 1 month
occurrence of sustained supra-ventricular arrhythmia
occurrence of sustained supra-ventricular arrhythmia (AF, atrial flutter) during the analysis at 6 month (Holter ECG)
Measured: at 6 month
occurrence of sustained supra-ventricular arrhythmia
occurrence of sustained supra-ventricular arrhythmia (AF, atrial flutter) during the analysis at 12 month (Holter ECG)
Measured: at 12 month
Secondary outcomes (6)
characteristics of these detected arrhythmias
characteristics of these detected arrhythmias : time to onset
Measured: 24 hours post-intervention to 12 months
characteristics of these detected arrhythmias
characteristics of these detected arrhythmias : duration
Measured: 24 hours post-intervention to 12 months
characteristics of these detected arrhythmias
characteristics of these detected arrhythmias : recurrence
Measured: 24 hours post-intervention to 12 months
symptoms related to the arrhythmia episode
symptoms related to the arrhythmia episode
Measured: 24 hours post-intervention to 12 months
hospitalization related to arrhythmia
hospitalization related to arrhythmia
Measured: 24 hours post-intervention to 12 months
occurrence of a neurological accident.
occurrence of a neurological accident.
Measured: 24 hours post-intervention to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Mar 2020
- Primary completion1 Mar 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Leclercq, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290052
- Sponsor's protocol ID
- RECHMPL19_0517
- Acronym
- AFEPFO
- Status last verified
- Apr 2022
- First submitted
- 11 Feb 2020
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation on Holter Monitoring After Percutaneous Patent Foramen Ovale Closure : a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04290052
- Acronym / sponsor ID
- AFEPFO / RECHMPL19_0517
- Conditions
- Stroke
- Keywords
- Cryptogenic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An increased risk of atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized trials but systematic screening of AF was not performed in these studies. Purpose: The objective of this study was to evaluate incidence of AF in patients who underwent percutaneous PFO closure with serial 24-hours ambulatory ECG (AECG) monitoring during 6 months follow-up. Primary endpoint was incidence of AF on ECG monitoring. Secondary endpoints were clinical outcomes (symptoms, hospitalization from cardiovascular causes, ischemic stroke, or bleeding) up to 6 month follow-up.
Detailed description
This is a prospective, bicentric, observational cohort study which will be performed in University hospital center of Montpellier and Nîmes The study will include all consecutive patients, admitted for a percutaneous PFO closure after an ischemic stroke (IS) or a transient ischemic attack (TIA) of cryptogenic origin, or after the occurrence of a decompression illness during scuba diving. Patients eligible for the closure of a FOP in prevention of the recurrence of stroke or TIA of cryptogenic origin, was systematically evaluated for exclusion of supraventricular arrhythmia in accordance with international recommendations. This evaluation included a 12-lead ECG as well as an extended electrocardiographic monitoring lasting more than or equal to 24 hours (most frequently, performing a 72-hour ECG Holter). All patients previously has a transesophageal ultrasound (TEE) allowing to retain the diagnosis of PFO, to assess the presence or not of an atrial septum aneurysm (ASA) associated with PFO and to quantify the right to left shunt thanks to a contrast test potentiated by a Valsalva maneuver. Exclusion criteria included interatrial defect with left to right and others indications for PFO closure that cryptogenic stroke or decompression illness. Indication of PFO closure is always validated by a cardio neurological team.
The primary objective of the study was incidence of AF defined as an irregular rhythm without discernible P waves lasting at least 30 seconds on ECG monitoring during the 6-month follow-up. The secondary objectives were to evaluate the characteristics of the supra-ventricular arrhythmias (delay in onset, duration, recurrent nature), incidence of others arrhythmia, symptoms, and prognostic implications of AF (hospitalization , need of curative anticoagulation, need for cardioversion and occurrence of neurological accident documented by imagery (ischemic stroke or TIA). The investigators also evaluated risk factors for occurrence of arrhythmia.
A total of 100 patients included during 1 year is expected
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient at least 18 years old, benefiting from percutaneous closure of the FOP after a cryptogenic stroke (indication validated during a multidisciplinary meeting with neurologists and cardiologists)
Key inclusion criteria (2 listed)
- Men or women over the age of 18 to 60
- Benefiting from the closure of the FOP percutaneously after a cryptogenic ischemic stroke or a TIA (indication validated during a multidisciplinary meeting with neurologists and cardiologists)
Key exclusion criteria (3 listed)
- Inability to perform a 24h ECG Holter
- Pregnant or lactating women
- Vulnerable people
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occurrence of sustained supra-ventricular arrhythmia
Time frame: the 24-hour post-intervention
occurrence of sustained supra-ventricular arrhythmia (AF, atrial flutter) during the analysis the 24-hour Holter ECG performed post-intervention
occurrence of sustained supra-ventricular arrhythmia
Time frame: at 1 month
occurrence of sustained supra-ventricular arrhythmia (AF, atrial flutter) during the analysis at 1 month (Holter ECG)
occurrence of sustained supra-ventricular arrhythmia
Time frame: at 6 month
occurrence of sustained supra-ventricular arrhythmia (AF, atrial flutter) during the analysis at 6 month (Holter ECG)
occurrence of sustained supra-ventricular arrhythmia
Time frame: at 12 month
occurrence of sustained supra-ventricular arrhythmia (AF, atrial flutter) during the analysis at 12 month (Holter ECG)
6 secondary outcomes
characteristics of these detected arrhythmias
Time frame: 24 hours post-intervention to 12 months
characteristics of these detected arrhythmias
Time frame: 24 hours post-intervention to 12 months
characteristics of these detected arrhythmias
Time frame: 24 hours post-intervention to 12 months
symptoms related to the arrhythmia episode
Time frame: 24 hours post-intervention to 12 months
hospitalization related to arrhythmia
Time frame: 24 hours post-intervention to 12 months
occurrence of a neurological accident.
Time frame: 24 hours post-intervention to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Leclercq, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of sustained supra-ventricular arrhythmia (time frame: the 24-hour post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.