Related Experiment Video
Updated: May 23, 2026
10:52
Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
PFO closuRE and CryptogenIc StrokE (PRECISE) registry: a multi-center, international registry
Jochen Wöhrle1, Bernard Bertrand, Lars Søndergaard
1Department of Internal Medicine II, Cardiology, University of Ulm, Albert-Einstein-Allee 23, 89081 Ulm, Germany. jochen.woehrle@uniklinik-ulm.de
Summary
The Premere™ PFO closure device effectively closed patent foramen ovale (PFO) in patients with a history of stroke or transient ischemic attack (TIA). This study found no recurrent stroke or TIA events after implantation.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Neurology
Background:
- Patent foramen ovale (PFO) is associated with cryptogenic stroke and transient ischemic attack (TIA).
- The Premere™ PFO closure device is designed for PFO closure with minimal septal distortion.
Purpose of the Study:
- To evaluate the risk of stroke or TIA in patients following implantation of the Premere™ PFO closure device.
- To assess the clinical outcomes and safety of the Premere™ device in PFO closure.
Main Methods:
- A multicenter, prospective observational registry (PRECISE) was conducted.
- 267 patients with a history of stroke or TIA and a right-to-left shunt underwent successful Premere™ PFO closure device implantation.
- Follow-up was conducted according to routine clinical practice, with a mean follow-up of 11 months.
Main Results:
- No residual shunt was observed in 71% of patients; small, moderate, or large residual shunts were present in 16.8%, 5.6%, and 6.5% respectively.
- No stroke or TIA events occurred during the follow-up period.
- Adverse events included one sudden death, atrial fibrillation in 1.9% of patients, and one thrombus in a patient with thrombophilic diathesis.
Conclusions:
- The Premere™ PFO closure device demonstrated good clinical results in the PRECISE registry for PFO closure in patients with a history of stroke or TIA.
- The device was associated with no recurrent stroke or TIA events, indicating its safety and efficacy.
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