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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: 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: 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: 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: 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: NCT04549272 Not yet recruiting - Clinical trials for Patent Foramen Ovale

Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale

Start date: October 2022
Phase:
Study type: Observational

Patent foramen ovale arises from the incomplete postnatal fusion of the septum primum and secundum and can cause paradoxical embolism in adults. In case of cerebral ischemic stroke, the correlation with the patent foramen ovale is based on probabilistic approach. For this reason, continuous research is indispensable, especially according to new approaches, to offer tools capable of guiding in case of adverse event with greater certainty and even better to prevent it. Thus, this study aims to: 1) evaluate the microstructural brain damage through advanced MRI analysis in patients with patent foramen ovale; 2) evaluate how much the degree of the shunt can affect brain damage. In order to do this, this study aims to evaluate advanced brain imaging in a cohort of patients with patent foramen ovale to identify the development of early vascular damage.

NCT ID: NCT04288596 Not yet recruiting - Clinical trials for Patent Foramen Ovale

Canadian Adult Congenital Heart Disease Intervention Registry

C-ACHDiR
Start date: April 1, 2020
Phase:
Study type: Observational [Patient Registry]

The ACHDi Registry study will create a foundational database for adult congenital heart disease interventions. This Pan-Canadian Registry will collect clinical and patient-reported information that will enable the evaluation of care processes and outcomes in five most common ACHDi interventions by enabling prospective and retrospective registry-based studies to answer important clinical practice and policy-relevant questions.

NCT ID: NCT02383836 Not yet recruiting - Clinical trials for Patent Foramen Ovale

Influence of Position on Detection of Patent Foramen Ovale by Simultaneous Transesophageal Echo and Transcranial Doppler

Start date: March 2015
Phase: N/A
Study type: Observational

Patients will have simultaneous Transesophageal Echo (TEE) and Transcranial Doppler (TCD) performed and a comparison of timing, sensitivity and intensity of intravenously injected bubbles will be determined.