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PFO - Patent Foramen Ovale clinical trials

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NCT ID: NCT06203873 Not yet recruiting - Migraine Clinical Trials

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

BioMetal
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Migraine is one of the most common chronic neurological disorders, posing a significant global public health concern. Patent Foramen Ovale (PFO) is the most common congenital heart anomaly in adults. Mechanisms linking PFO to migraine include cortical spreading depression, vascular active substance theory, impaired cerebral autoregulation, and genetic susceptibility. Understanding these mechanisms holds promise for overcoming challenges in the prevention and treatment of migraines in PFO patients. At least 11 observational studies, comprising 1,632 subjects, described the efficacy of PFO closure in cryptogenic stroke. Of these, 34% had migraines, and percutaneous PFO closure reportedly reduced migraine days by 81% (with a reduction of over 50% in monthly migraine days). Prospective randomized controlled trials (PRIMA and PREMIUM trials) assessing the Amplatzer® PFO Occluder showed significant benefits in most secondary endpoints, with a pooled analysis indicating its safety and effectiveness compared to medical therapy.While traditional metal PFO closure studies suggest symptom relief, reports also mention potential new-onset or worsened migraines post-closure. Proposed mechanisms include platelet activation, microthrombus formation, nickel allergy, and septal deformation or stretching inducing the release of migraine-related vascular active substances. However, these theories are closely tied to the presence of permanent metal implants. Addressing these concerns, the MemoSorb® biodegradable PFO Occluder system, approved by the National Medical Products Administration (NMPA) in September 2023, offers an innovative solution. Developed collaboratively by the National Biomedical Materials Engineering Technology Research Center, Professor Wang Yunbing's team, Professor Pan Xiangbin's team from Fuwai Hospital, Chinese Academy of Medical Sciences, and HeartTech Medical, this groundbreaking technology represents a shift from metal to degradable materials. The occluder serves as a temporary bridge post-implantation, gradually degrading with endothelialization, facilitating comprehensive self-repair. This intervention concept theoretically avoids the lifelong complications associated with traditional metal occluders, effectively reducing postoperative symptoms like migraines and dizziness. To assess and compare the treatment outcomes, especially in relieving migraines, a prospective, single-blind, randomized controlled study has been designed for patients with patent foramen ovale and migraine, comparing the novel biodegradable occluder with the metal occluder.

NCT ID: NCT06046508 Recruiting - Migraine Headache Clinical Trials

Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)

MANET
Start date: May 18, 2023
Phase:
Study type: Observational

This is a multicenter prospective observational study aimed to asses whether a specific prothrombotic platelet phenotype can discern migraine patients with PFO (patent forame ovale) - related symptoms from patients with incidental PFO. The study will also explore additional distinguishing features of causal and incidental PFO using a metabolomics approach. It involves the enrollment of well-characterized patient cohorts and an ex vivo approach using comparative cell biology models that reproduce the most critical aspects of the clinical scenario.

NCT ID: NCT06033937 Recruiting - Migraine Clinical Trials

COMPETE Cohort Study

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

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 multi-center cohort study aiming to find the correlation between PFO closure and migraine attacks.

NCT ID: NCT05529901 Recruiting - Stroke Clinical Trials

Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

GSO-PFO PMS
Start date: October 3, 2022
Phase:
Study type: Observational

The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.

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: NCT04433520 Recruiting - Clinical trials for PFO - Patent Foramen Ovale

Trevisio Post-Approval Study

TrevisioPAS
Start date: September 14, 2020
Phase:
Study type: Observational

A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices. NOTE: The enrollment for the VSD cohort is still recruiting (3 subjects at this moment); therefore, the overall status of the study is Recruiting.

NCT ID: NCT04349995 Active, not recruiting - Clinical trials for PFO - Patent Foramen Ovale

Amplatzer PFO Occluder Post-marketing Surveillance Study

PFO PMS Jpn
Start date: October 1, 2019
Phase:
Study type: Observational

The purpose of the Amplatzer PFO Occluder post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.

NCT ID: NCT04100135 Active, not recruiting - Migraine Clinical Trials

GORE® CARDIOFORM Septal Occluder Migraine Clinical Study

RELIEF
Start date: February 5, 2021
Phase: N/A
Study type: Interventional

Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief

NCT ID: NCT04029233 Active, not recruiting - Stroke Clinical Trials

The PROOF Trial - Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO

PROOF
Start date: October 3, 2019
Phase:
Study type: Observational

Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

NCT ID: NCT03821129 Recruiting - Stroke Clinical Trials

GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

REDUCE PAS
Start date: July 25, 2019
Phase: N/A
Study type: Interventional

This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.