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Patent Foramen Ovale clinical trials

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NCT ID: NCT05592301 Recruiting - Clinical trials for Patent Foramen Ovale

Patent Foramen Ovale (PFO) and Risk of Perioperative Stroke

CAPPRES
Start date: July 7, 2023
Phase:
Study type: Observational

This is a multi-centre, prospective cohort study to determine if asymptomatic PFO is a risk factor for developing perioperative overt and covert stroke in patients undergoing non-cardiac surgery.

NCT ID: NCT05561660 Recruiting - Migraine Clinical Trials

COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)

Start date: October 1, 2022
Phase: Phase 4
Study type: Interventional

Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a prospective, double-blind, multi-center, and randomized study designed to test the effectiveness of migraine alleviation by performing percutaneous closure of patent foramen ovale in patients who are also diagnosed with PFO and migraine.

NCT ID: NCT05546320 Recruiting - Migraine Clinical Trials

Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale

COMPETE
Start date: October 15, 2022
Phase: Phase 4
Study type: Interventional

Migraine attack is an episodic disorder that affects approximately 12% of the population. Previous studies have shown that 41-48% of migraineur have a combination of patent foramen ovale (PFO). Clinical observational studies have been linking medication therapies which include anticoagulation and anti-platelet therapy with the effectiveness in improving migraine symptoms and reducing the frequency of attacks in patients combined with a PFO. However, it has been unclear whether the effectiveness of anticoagulation or anti-platelet therapy outweigh the conventional migraine medication therapy, as a result, we designed a multi-center randomized clinical trial aiming to examine the effectiveness of anticoagulation versus anti-platelet versus migraine medication therapy in migraine patients with PFO and provide a clinical guidance for migraineur.

NCT ID: NCT05537753 Recruiting - Clinical trials for Patent Foramen Ovale

Encore PFO Closure Device - The PerFOrm Trial

Start date: July 12, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.

NCT ID: NCT05387954 Not yet recruiting - Clinical trials for Patent Foramen Ovale

PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years

CLOSE-2
Start date: June 1, 2022
Phase: Phase 3
Study type: Interventional

To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt (> 20 microbubbles) or a PFO associated with an ASA (> 10 mm), and an otherwise unexplained ischemic stroke.

NCT ID: NCT05360771 Not yet recruiting - Clinical trials for Patent Foramen Ovale

Study on the Safety and Effectiveness of the SnowyTM PFO Closure System

Start date: October 20, 2023
Phase: N/A
Study type: Interventional

To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale

NCT ID: NCT05312554 Withdrawn - Clinical trials for Patent Foramen Ovale

Safety and Efficacy of IrisFIT™ Patent Foramen Ovale Occluders

Start date: April 12, 2022
Phase: N/A
Study type: Interventional

To evaluate the performance of patent foramen ovale (PFO) device developed by Lifetech Technology (Shenzhen) Co., LTD

NCT ID: NCT05213104 Active, not recruiting - Clinical trials for Patent Foramen Ovale

Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia

AFLOAT
Start date: March 23, 2022
Phase: Phase 3
Study type: Interventional

About 30% of ischemic strokes are cryptogenic. Patent Foramen Ovale (PFO) is present in about 25% of the general population. In cryptogenic strokes, PFO has been shown to be overrepresented and recent intervention studies have confirmed that PFO has a causal link with stroke. In patients with recent cryptogenic stroke, these randomized studies have shown at least 50%-reduction of recurrent neurological events after PFO percutaneous closure compared with medical therapy alone. At the The risk of AF reported in these studies in certainly largely underestimated as only symptomatic and recorded episodes of AF have been declared. Patients often report palpitations without a dia gnosis of AF made on the ECG or a Holter. Long term ECG monitoring provides more accurate data on AF incidence. Administration of flecainide has been shown to be effective in preventing Atrial arrhythmia and may be useful in preventing these Atrial arrhythmia(AA) episodes after PFO closure. To the knowledge of the investigators, there is no study assessing the efficacy of any antiarrhythmic drug in the prevention of AFafter PFO closure. AFLOAT will be the first randomized study to possibly validate flecainide to prevent Atrial arrhythmia in these patients.

NCT ID: NCT05069558 Recruiting - Stroke Clinical Trials

Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion

OCCLUFLEX
Start date: April 30, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE).

NCT ID: NCT04950192 Active, not recruiting - Stroke Clinical Trials

Philips Intracardiac Echocardiography (ICE) Clinical Registry

Start date: October 25, 2021
Phase:
Study type: Observational [Patient Registry]

The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.