Atrial Fibrillation New OnsetNCT04898361
PFO Occlusion and Atrial Fibrillation
A study testing PFO closure in people with Atrial Fibrillation New Onset and Embolic Stroke of Undetermined Source, run by University Hospital, Saarland at 1 site in Germany.
Trial summary
Interventional closure of patent foramen ovale (PFO) associates with reduced risk of stroke recurrence in patients with cryptogenic ischemic stroke as reported in the recent CLOSE and REDUCE trials. The long-term follow-up results of the RESPECT and DEFENSE-PFO trial confirmed these findings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset, Embolic Stroke of Undetermined Source, Patent Foramen Ovale
- What is being tested?
- PFO closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2020to Jun 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous embolic stroke with undetermined source with…
- palpitations with clinical indication for an electrophysiological study (control group)
- PFO and clinical indication for interventional PFO closure according to current guidelines (intervention group)
- Sinus rhythm at time of inclusion with no history of AF
- Planned EP study due to reported palpitations or documented burden of non-sustained atrial arrythymias (>100 atrial ectopic beats /24 hours, atrial tachycardia)
- Written informed consent
Who cannot join
- previously documented AF
- indication for therapeutic anticoagulation
- uncontrolled diabetes mellitus
- acute coronary syndrom or acute cardiac decompensation within the last 6 months before enrollment
- enrolled in another study
- BMI > 40 kg/m²
Show all 9Show fewer
- patients who are pregnant of breastfeeding life expectancy < 6 months
- relevant peripheral artery disease
- substance abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum des Saarlandes
Homburg, Saarland, 66421
Christian Ukena, MD, 004968411615912, christian.ukena@uks.eu
Dominic Millenaar, MD, 004968411615912, dominic.millenaar@uks.eu
About this study
Official title: Electrophysiological and Echocardiographic PREDICTors of Atrial Fibrillation Following Interventional Closure of Patent Foramen Ovale in Cryptogenic Stroke: PREDICT-AF-PFO
Interventional closure of patent foramen ovale (PFO) associates with reduced risk of stroke recurrence in patients with cryptogenic ischemic stroke as reported in the recent CLOSE and REDUCE trials. The long-term follow-up results of the RESPECT and DEFENSE-PFO trial confirmed these findings. PFO closure is therefore recommended in patient with cryptogenic ischemic stroke and PFO according to the current German interdisciplinary guidelines. It is likely that the number of PFO closure procedures will increase significantly in the near future. However, new onset atrial fibrillation (AF) appears to increase in patients following this procedure. In the REDUCE study, new onset atrial fibrillation was detected in 6.6% patients in the PFO closure group compared with 0.4% in the control group (medical treatment); 59% of these patients were diagnosed within the first two weeks following the procedure and 83% within 45 days, respectively. These results were consistent with the CLOSE study: AF was detected in 4.6% patients in the intervention group vs. 0.9% in the control group. Up until today, markers to identify and quantify the individual risk of AF onset are lacking. Furthermore, under-reporting and under-detection of AF occurrence after PFO closure is likely. This study is designed to to assess the prevalence and and identification of electrophysiological and echocardiographic parameters of new-onset AF.
- Conditions
- Atrial Fibrillation New Onset, Embolic Stroke of Undetermined Source, Patent Foramen Ovale
- Being tested
- PFO closure
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFO closureProcedure or surgery
Interventional closure of a patent foramen oval preceded by an electrophysiological study
| Study group | Role | What they receive |
|---|---|---|
| PFO closure | Active comparator | Patients with embolic stroke of undetermined source (ESUS) with patent foramen ovale (PFO) eligible for interventional PFO occlusion receiving a structured electrophysiological study due to palpitations before the PFO closure. Extensive cardiac monitoring. Receives: Procedure: PFO closure |
| NO PFO | No intervention | Patients with embolic stroke of undetermined source (ESUS) with NO patent foramen ovale (PFO) receiving a structured electrophysiological study due to palpitations. Extensive cardiac monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline heart rhythm, e.g. new-onset atrial fibrillation
Rate of detection of new-onset atrial fibrillation with Holter and loop recorder monitoring after electrophysiological study
Measured: 1, 3, 6, 12 months
Secondary outcomes (16)
Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study
Atrial refractory periods are measured and atrial arrhythmias are induced during the electrophysiological study. Measurement: electrophysiological study, Unit of measure: Rate of patients with induced AF during stimulation
Measured: 1 month
Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study
Atrial refractory periods are measured and atrial arrhythmias are induced during the electrophysiological study. Measurement: electrophysiological study, Unit of measure: Rate of patients with induced AF during stimulation
Measured: 3 months
Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study
Atrial refractory periods are measured and atrial arrhythmias are induced during the electrophysiological study. Measurement: electrophysiological study, Unit of measure: Rate of patients with induced AF during stimulation
Measured: 6 months
Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study
Atrial refractory periods are measured and atrial arrhythmias are induced during the electrophysiological study. Measurement: electrophysiological study, Unit of measure: Rate of patients with induced AF during stimulation
Measured: 12 months
Change in left atrial morphology (LA volume index) following PFO closure
Assessment of the change in left atrial morphology and function (LA volume index) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA volume index, physiologocal parameter
Measured: 1 month
Change in left atrial function (LA strain) following PFO closure
Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter
Measured: 1 month
Change in new-onset AF following PFO closure
Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG
Measured: 1 month
Change in left atrial morphology (LA volume index) following PFO closure
Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter
Measured: 3 months
Change in left atrial function (LA strain) following PFO closure
Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter
Measured: 3 months
Change in new-onset AF following PFO closure
Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG
Measured: 3 months
Change in left atrial morphology (LA volume index) following PFO closure
Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter
Measured: 6 months
Change in left atrial function (LA strain) following PFO closure
Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter
Measured: 6 months
Change in new-onset AF following PFO closure
Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG
Measured: 6 months
Change in left atrial morphology (LA volume index) following PFO closure
Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter
Measured: 12 months
Change in left atrial function (LA strain) following PFO closure
Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter
Measured: 12 months
Change in new-onset AF following PFO closure
Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start15 Jan 2020
- Primary completionJun 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation New OnsetStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Ukena, University Hospital, Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898361
- Sponsor's protocol ID
- PREDICT-AF PFO
- Status last verified
- May 2021
- First submitted
- 13 Sep 2020
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological and Echocardiographic PREDICTors of Atrial Fibrillation Following Interventional Closure of Patent Foramen Ovale in Cryptogenic Stroke: PREDICT-AF-PFO
- ClinicalTrials.gov ID
- NCT04898361
- Acronym / sponsor ID
- PREDICT-AF PFO
- Conditions
- Atrial Fibrillation New Onset, Embolic Stroke of Undetermined Source, Patent Foramen Ovale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 24 May 2021 (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.
Interventional closure of patent foramen ovale (PFO) associates with reduced risk of stroke recurrence in patients with cryptogenic ischemic stroke as reported in the recent CLOSE and REDUCE trials. The long-term follow-up results of the RESPECT and DEFENSE-PFO trial confirmed these findings. PFO closure is therefore recommended in patient with cryptogenic ischemic stroke and PFO according to the current German interdisciplinary guidelines. It is likely that the number of PFO closure procedures will increase significantly in the near future. However, new onset atrial fibrillation (AF) appears to increase in patients following this procedure. In the REDUCE study, new onset atrial fibrillation was detected in 6.6% patients in the PFO closure group compared with 0.4% in the control group (medical treatment); 59% of these patients were diagnosed within the first two weeks following the procedure and 83% within 45 days, respectively. These results were consistent with the CLOSE study: AF was detected in 4.6% patients in the intervention group vs. 0.9% in the control group. Up until today, markers to identify and quantify the individual risk of AF onset are lacking. Furthermore, under-reporting and under-detection of AF occurrence after PFO closure is likely. This study is designed to to assess the prevalence and and identification of electrophysiological and echocardiographic parameters of new-onset AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFO closure | Active comparator | Procedure: PFO closurePatients with embolic stroke of undetermined source (ESUS) with patent foramen ovale (PFO) eligible for interventional PFO occlusion receiving a structured electrophysiological study due to palpitations before the PFO closure. Extensive cardiac monitoring. |
| NO PFO | No intervention | –Patients with embolic stroke of undetermined source (ESUS) with NO patent foramen ovale (PFO) receiving a structured electrophysiological study due to palpitations. Extensive cardiac monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Previous embolic stroke with undetermined source with…
- palpitations with clinical indication for an electrophysiological study (control group)
- PFO and clinical indication for interventional PFO closure according to current guidelines (intervention group)
- Sinus rhythm at time of inclusion with no history of AF
- Planned EP study due to reported palpitations or documented burden of non-sustained atrial arrythymias (>100 atrial ectopic beats /24 hours, atrial tachycardia)
Key exclusion criteria (9 listed)
- previously documented AF
- indication for therapeutic anticoagulation
- uncontrolled diabetes mellitus
- acute coronary syndrom or acute cardiac decompensation within the last 6 months before enrollment
- enrolled in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFO closureInterventional closure of a patent foramen oval preceded by an electrophysiological study | Procedure or surgery | PFO closure |
Primary outcome
Change in baseline heart rhythm, e.g. new-onset atrial fibrillation
Time frame: 1, 3, 6, 12 months
Rate of detection of new-onset atrial fibrillation with Holter and loop recorder monitoring after electrophysiological study
16 secondary outcomes
Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study
Time frame: 1 month
Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study
Time frame: 3 months
Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study
Time frame: 6 months
Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study
Time frame: 12 months
Change in left atrial morphology (LA volume index) following PFO closure
Time frame: 1 month
Change in left atrial function (LA strain) following PFO closure
Time frame: 1 month
Change in new-onset AF following PFO closure
Time frame: 1 month
Change in left atrial morphology (LA volume index) following PFO closure
Time frame: 3 months
Change in left atrial function (LA strain) following PFO closure
Time frame: 3 months
Change in new-onset AF following PFO closure
Time frame: 3 months
Change in left atrial morphology (LA volume index) following PFO closure
Time frame: 6 months
Change in left atrial function (LA strain) following PFO closure
Time frame: 6 months
Change in new-onset AF following PFO closure
Time frame: 6 months
Change in left atrial morphology (LA volume index) following PFO closure
Time frame: 12 months
Change in left atrial function (LA strain) following PFO closure
Time frame: 12 months
Change in new-onset AF following PFO closure
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFO closure in people with Atrial Fibrillation New Onset and Embolic Stroke of Undetermined Source, run by University Hospital, Saarland at 1 site in Germany.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 May 2021. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline heart rhythm, e.g. new-onset atrial fibrillation (time frame: 1, 3, 6, 12 months). 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 24 May 2021.