An interventional study of PFO closure in Atrial Fibrillation New Onset, Embolic Stroke of Undetermined Source and Patent Foramen Ovale, sponsored by University Hospital, Saarland. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-24.
Sponsored by University Hospital, Saarland · Not applicable, Interventional, and Treatment
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Among 21 studies in Foramen Ovale, Patent with a site in Germany — 3 open to participants now, 6 under way, none of them phase 3. Foramen Ovale, Patent · Germany.
Among the 21 studies in Foramen Ovale, Patent with a site in Germany, this one is the 11th largest by planned enrollment of the 13 interventional ones that give a count, is one of 3 that started in 2020, is one of 13 with no phase, and was the 17th registered.
136 studies on the registry are indexed under Foramen Ovale, Patent; 47 are open to participants now.
Browse Foramen Ovale, Patent studies →3 of the 21 studies in Foramen Ovale, Patent with a site in Germany are open now. Recruiting first, the newest first:
Giuseppe Tarantini · Sites in Germany
Ages 18–65
Abbott Medical Devices · Sites in Germany, United States, Denmark and 7 more countries
Lifetech Scientific (Shenzhen) Co., Ltd. · Sites in Germany, Korea, Republic of
Ages 18–85
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 34 Foramen Ovale, Patent studies recruiting now, 11 (32%) set no upper age limit and 19 (56%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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21 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2020.
This study's planned enrollment of 50 is below the median of 154 across 69 interventional studies indexed under Foramen Ovale, Patent.
Median enrollment 85 across the 13 interventional studies, 582 across the 7 observational. Of the 9 that completed or were terminated, 2 (22%) have results posted.
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18 of 21 have an industry lead sponsor. The 10 most frequent:
University Hospital, Saarland is the lead sponsor of 43 studies on the registry; none are open to participants now.
University Hospital, Saarland has 1 study filed under Foramen Ovale, Patent — fewer than ten, so there is no comparison to draw.
1 of the studies in Foramen Ovale, Patent with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06120270Lifetech Scientific (Shenzhen) Co., Ltd.CeraFlex PFO Closure System PMCF Study | 2026-12 |
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Among the 21 studies in Foramen Ovale, Patent with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: PFO closure
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.
Interventional closure of a patent foramen oval preceded by an electrophysiological study
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
Time frame: 1, 3, 6, 12 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 month
Change in new-onset AF following PFO closure
Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG
Time frame: 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
Time frame: 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
Time frame: 3 months
Change in new-onset AF following PFO closure
Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG
Time frame: 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
Time frame: 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
Time frame: 6 months
Change in new-onset AF following PFO closure
Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG
Time frame: 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
Time frame: 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
Time frame: 12 months
Change in new-onset AF following PFO closure
Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG
Time frame: 12 months
Plan to share: No
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Started Jan 2020 (actual). Primary completion is estimated for Jun 2021, 17 months after the start.
Of 31 interventional studies with no phase under Foramen Ovale, Patent, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 100. This study's planned 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Saarland