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Efficacy of symptomatic patent foramen ovale closure: a cohort study

Efficacy of symptomatic patent foramen ovale closure: a cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300067924
Enrollment
Unknown
Registered
2023-01-31
Start date
2023-02-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patent foramen ovale

Interventions

Case series:N/A

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 70 Years

Inclusion criteria

Inclusion criteria: Study object: For patients with migraine combined with PFO and meeting the indications of occlusion, all candidate subjects must meet all the following conditions: 1. Age >= 16; 2. History of migraine, migraine meets the diagnostic criteria of International Classification of Headache Disorders (ICHD-3 Trial Edition) formulated by the International Headache Society in 2013; 3. The neurology medicine treatment of migraine dysmenorrhea is ineffective or ineffective, and the patient has a strong desire to block the treatment; 4. Contrast transcranial Doppler (c-TCD) indicated that the right to left shunt flow was medium to large; 5. Subjects volunteered to participate in the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: Candidates will be excluded from the study if any of the following conditions are met: 1. Headache caused by other causes, such as intracranial space occupying lesions, intracranial aneurysms, cerebral vascular malformations, cerebral vascular stenosis, etc; 2. Long term chronic pain history except headache; Patients with cerebral hemorrhage, cerebral infarction and acute cerebrovascular disease within 3.1 months; 4. Obstruction caused by thrombosis of pelvic cavity or inferior vena cava, thrombosis in heart, and severe infection; 5. Patients with other organic heart disease requiring surgical intervention; 6. Patients with abnormal coagulation mechanism, autoimmune disease, severe heart, liver, kidney failure, etc., who cannot complete transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), or c-TCD; 7. History of severe pulmonary hypertension, malignant tumor, mental system disease, drug and alcohol abuse and dependence; 8. People who are allergic to nickel titanium metal; 9. Currently participating in other clinical research projects or less than three months from the end of the last clinical research.

Design outcomes

Primary

MeasureTime frame
Migraine Disability Assessment Questionnaire;Headache Impact Determination-6 (HIT-6) score;Contrast transcranial Doppler;Biological metabolomics index;

Countries

China

Contacts

Public ContactZhang Hao

The First Affiliated Hospital of Nanjing Medical University

haozhanghh@163.com+86 13851530428

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026