Patent Foramen Ovale
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CLINICAL_TRIALS trial_result · 2026-06-09Clinical Trial Results: GORE® CARDIOFORM Septal Occluder Migraine Clinical Study [NA]
Clinical trial results for the GORE CARDIOFORM Septal Occluder in patients with migraine and patent foramen ovale have been posted, with the…
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CLINICAL_TRIALS trial_result · 2026-04-22Clinical Trial Update: Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale [Phase 2]
A Phase 2 trial comparing the effect of medication therapy on migraine symptoms in patients with patent foramen ovale; the study has complet…
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CLINICAL_TRIALS trial_result · 2026-03-16Clinical Trial Update: Trevisio Post-Approval Study
Trevisio post-approval study by Abbott Medical Devices has completed and posted results (as of 2026-03-16). The study covers patent foramen …
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CLINICAL_TRIALS trial_result · 2026-03-04Clinical Trial Update: Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study [NA]
Clinical trial update for the PROTEA-PFO early feasibility study evaluating percutaneous repair of the atrial septum with a novel PFO occlud…
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CLINICAL_TRIALS trial_result · 2025-11-20Clinical Trial Update: Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
Post-marketing surveillance update for the GORE CARDIOFORM Septal Occluder in Japan, monitoring safety and outcomes related to stroke and TI…
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CLINICAL_TRIALS trial_result · 2025-07-24Clinical Trial Update: Cerebral Microembolization Associated With PFO Closure
This clinical trial update notes a study investigating cerebral microembolization associated with closure of patent foramen ovale (PFO) and …
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CLINICAL_TRIALS trial_result · 2025-06-06Clinical Trial Update: Comparison of Lower vs Upper Extremity Injection Agitated Saline to Identify Patent Foramen Ovale With Echocardiography [NA]
Completed clinical trial comparing lower vs upper extremity injection of agitated saline to identify patent foramen ovale using echocardiogr…
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CLINICAL_TRIALS trial_result · 2025-05-13Clinical Trial Update: Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study
This update provides information on a clinical trial examining atrial fibrillation before and after patent foramen ovale closure. The study …
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CLINICAL_TRIALS trial_result · 2025-02-06Clinical Trial Update: Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder [NA]
A completed clinical trial update evaluating whether nickel sensitization occurs after percutaneous implantation of a patent foramen ovale o…
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CLINICAL_TRIALS trial_result · 2025-01-06Clinical Trial Update: Philips Intracardiac Echocardiography (ICE) Clinical Registry
Completed Philips Intracardiac Echocardiography (ICE) Clinical Registry with results posted. The registry studied patients with atrial fibri…
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CLINICAL_TRIALS trial_result · 2024-08-30Clinical Trial Update: Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up
This clinical trial update reports the completion of post-market clinical follow-up for the Lifetech Cera PFO Occluder. The study targeted p…
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CLINICAL_TRIALS trial_result · 2024-07-16Clinical Trial Update: PFO tRanscatether Occlusion Long-term Outcomes National Group (PROLONG) Registry
This clinical trial update reports long-term outcomes from the PROLONG registry evaluating patent foramen ovale closure with transcatheter d…
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CLINICAL_TRIALS trial_result · 2024-04-05Clinical Trial Update: Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia [Phase 3]
Phase 3 trial assessing whether flecainide reduces risk related to patent foramen ovale closure in patients with atrial arrhythmia or tachyc…
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CLINICAL_TRIALS trial_result · 2024-01-24Clinical Trial Update: RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt [NA]
A completed clinical trial evaluating RoBotic TCD Ultrasound Bubble studies versus transthoracic echocardiography for detecting right-to-lef…
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CLINICAL_TRIALS trial_result · 2023-01-09Clinical Trial Update: COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2) [Phase 4]
A Phase 4 trial evaluating the effect of a device closure in alleviating migraine associated with patent foramen ovale (PFO).
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CLINICAL_TRIALS trial_result · 2021-10-19Clinical Trial Update: pLatelEts And MigRaine iN patEnt foRamen Ovale [NA]
Completed clinical trial investigating pLatelEts and migraine in patients with patent foramen ovale; results posted in 2021.
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CLINICAL_TRIALS trial_result · 2020-07-30Clinical Trial Update: PREMIUM Migraine Trial [NA]
A completed randomized trial update for the PREMIUM Migraine Trial sponsored by Abbott Medical Devices; results posted in 2020.
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CLINICAL_TRIALS trial_result · 2019-02-04Clinical Trial Update: PRIMA PFO Migraine Trial [Phase 2]
Abbott Medical Devices reports that the PRIMA PFO Migraine Trial, a Phase 2 study investigating PFO closure for migraine, has been terminate…
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CLINICAL_TRIALS trial_result · 2017-10-19Clinical Trial Update: Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence [Phase 3]
Phase 3 trial comparing patent foramen ovale closure versus anticoagulants and antiplatelet therapy to prevent stroke recurrence has complet…
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CLINICAL_TRIALS trial_result · 2017-07-19Clinical Trial Update: Precutaneous High Risk Patent Foramen Ovale to Treat Migraine Headaches [Phase 2]
A Phase 2 trial is evaluating percutaneous closure of patent foramen ovale to treat migraine headaches; the current status is UNKNOWN.
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CLINICAL_TRIALS trial_result · 2017-06-29Clinical Trial Update: Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale (DEFENSE-PFO) [Phase 4]
This is a Phase 4 clinical trial update for DEFENSE-PFO comparing device closure to medical therapy in cryptogenic stroke patients with high…
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CLINICAL_TRIALS trial_result · 2017-06-27Clinical Trial Update: The Coherex FlatStent™ EF PFO Migraine Registry
The Coherex FlatStent EF PFO Migraine Registry, sponsored by Coherex Medical, studied patients with migraine and patent foramen ovale but ha…
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CLINICAL_TRIALS trial_result · 2016-09-08Clinical Trial Update: Correlation of Right-left Shunt Detection in Cardioembolism Etiology in Stroke Patient.
This clinical trial update reports a completed study evaluating right-to-left shunt detection for cardioembolic stroke etiology in patients …
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CLINICAL_TRIALS trial_result · 2015-11-13Clinical Trial Update: Right to Left Cardiac Shunt Detection [Phase 3]
Phase 3 trial evaluating detection of right-to-left cardiac shunts has been terminated, involving patent foramen ovale and atrial septal def…
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CLINICAL_TRIALS trial_result · 2014-04-24Clinical Trial Update: GORE® Septal Occluder European Union Clinical Evaluation [NA]
The EU clinical evaluation for the GORE Septal Occluder has completed. The trial evaluated closure of patent foramen ovale.