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Patent Foramen Ovale clinical trials

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NCT ID: NCT06413147 Not yet recruiting - Clinical trials for Patent Foramen Ovale

Long-term Procedural and Device Related Complications of PFO Closure

Start date: May 30, 2024
Phase:
Study type: Observational

We aimed to explore: (1)long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.

NCT ID: NCT06375070 Completed - Clinical trials for Patent Foramen Ovale

Anticoagulants for PFO Patients

Start date: August 2016
Phase:
Study type: Observational [Patient Registry]

Patients who underwent both bubble transcranial Doppler (bubble-TCD) and transoesophageal echocardiography (TEE) at our institution were consecutively enrolled in this real-world case-control study from August 2016 through August 2023. The patients were categorized into three groups based on the degree of the shunt observed: mild (3-9 bubbles), moderate (10-30bubbles), and severe (more than 30 bubbles). In cases with mild-shunt (small-size) PFO, post-procedural anticoagulation or PFO closure was administered. Subsequent to the interventions, the follow-up encompassed the recording of migraine remission, recurrent neurological incidents, instances of major bleeding, and mortality.

NCT ID: NCT06344494 Not yet recruiting - Atrial Fibrillation Clinical Trials

Cardiac Interventional ICE Imaging Trial

INTELICE
Start date: May 2024
Phase: N/A
Study type: Interventional

The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones. The evaluation will be conducted on patients undergoing planned intracardiac interventional process.

NCT ID: NCT06236776 Not yet recruiting - Clinical trials for Patent Foramen Ovale

AWARE Registry: Wearable ECG in Structural Heart Interventions

Start date: February 2024
Phase:
Study type: Observational

This study is a multi-center (Sinchon Severance hospital / Gangnam Severance hospital), prospective cohort observational study to patients who had undergone structural heart intervention including device closure for secundum type atrial septal defect or Patent foramen ovale. Transthoracic echocardiography will be performed before the procedure, immediately after, and at 6, 18, 30 months after the procedure. Wearable ECG monitoring (> 3 days) will be performed before the procedure or immediately after procedure. Demographic, laboratory, hemodynamic data during procedure, and non-invasive imaging dat are obtained.

NCT ID: NCT06192173 Completed - Migraine Clinical Trials

Patent Foramen Ovale Closure in Migraine

Start date: September 5, 2022
Phase:
Study type: Observational

The goal of this observational study is to retrospectively observe the effect of PFO closure and medication on migraine. The main questions it aims to answer are: - Whether PFO closure is more effective in the treatment of migraine than traditional medical treatment - What factors affect the effectiveness of migraine treatment ? Participants will undergo contrast transthoracic echocardiography to diagnose PFO and evaluate right-to-left shunt. They will be treated with medication and PFO closure respectively according to guidelines. HIT-6 and a questionnaire about migraine were obtained at the baseline and repeated at the 6-month and 12-month follow-up visits. Researchers will compare closure group and drug group to see efficacy of two groups in treating migraine.

NCT ID: NCT06156670 Not yet recruiting - Clinical trials for Patent Foramen Ovale

Russian Registry of Endovascular Closure of PFO

ENDOVAL
Start date: December 1, 2023
Phase:
Study type: Observational [Patient Registry]

The study will include all patients over 18 years of age who underwent endovascular closure of patent foramen ovale in medical centers in the Russian Federation, who gave written informed consent to the closure and provided personal data as part of inpatient medical care. The project participants will be 29 medical centers in the Russian Federation, where endovascular closure of patent foramen ovale is performed.

NCT ID: NCT06120270 Recruiting - Clinical trials for Patent Foramen Ovale

CeraFlex PFO Closure System PMCF Study

Start date: November 3, 2023
Phase:
Study type: Observational

The purpose of this study is to compile real-world data on patient outcomes and evaluate the procedural success and performance of the CeraFlex™ PFO Closure System.

NCT ID: NCT06113562 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Close Obstructive Sleep Apnea (OSA) Trial

Start date: August 28, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the benefits of patent foramen ovale (PFO) closure on patients with obstructive sleep apnea (OSA) and persistent hypoxia despite optimal therapy.

NCT ID: NCT05907694 Active, not recruiting - Clinical trials for Patent Foramen Ovale

Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure

STOP
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Data in older patients is limited and since the population ages and stroke remains a major cause of death and morbidity, randomized clinical trials are needed to better assess the benefit of PFO closure in this elderly population. Therefore, this study proposal sought to determine the efficacy of PFO closure for the prevention of recurrent stroke in older patients with PFO and cryptogenic stroke.

NCT ID: NCT05893758 Recruiting - Clinical trials for Patent Foramen Ovale

Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up

Start date: August 22, 2023
Phase:
Study type: Observational

The objective of this post-market registry is to assess the clinical use of the Lifetech Cera™ PFO Occluder in a real-world and on-label fashion.