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Foramen Ovale, Patent clinical trials

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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NCT ID: NCT05312554 Withdrawn - Clinical trials for Patent Foramen Ovale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: NCT05025475 Enrolling by invitation - Clinical trials for Foramen Ovale, Patent

Stitch Closure of PFO and Septal Repair (STITCH)

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent ischemic stroke.

NCT ID: NCT04987008 Recruiting - Clinical trials for Foramen Ovale, Patent

Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale

EPIC-FOPCohort
Start date: May 18, 2021
Phase:
Study type: Observational

stroke's risk is increased in patients with pulmonary embolism and PFO compared to patients without PFO. Does this increased risk persist years after pulmonary embolism ?

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.

NCT ID: NCT04946734 Recruiting - Migraine Clinical Trials

Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine

SPRING
Start date: August 12, 2021
Phase: Phase 3
Study type: Interventional

Effectivity and safety of PFO closure vs medicine in alleviating migraine (SPRING): a multicenter, random, case control study

NCT ID: NCT04926142 Active, not recruiting - Stroke Clinical Trials

Prevalence of Atrial Fibrillation in Cryptogenic Stroke With Patent Foramen Ovale Closure (PFO-AF) Study

PFO-AF
Start date: July 5, 2021
Phase:
Study type: Observational

This study aims to assess the incidence of atrial fibrillation (AF), documented using data recorded by an implantable Holter monitoring device (Reveal Linq, Medtronic) within 2 years after percutaneous closure of patent foramen ovale for cryptogenic stroke.