Clinical Trials Logo

Foramen Ovale, Patent clinical trials

View clinical trials related to Foramen Ovale, Patent.

Filter by:

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: 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: 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: 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: 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.