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Swartz Sheath With Angioplasty Guidewire-Assisted Technique for Patent Foramen Ovale Closure (STAGE-PFO)

RECRUITINGN/ASponsored by RenJi Hospital
Actively Recruiting
PhaseN/A
SponsorRenJi Hospital
Started2023-12-24
Est. completion2025-03-30
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06793969

Summary

The technical challenge in patent foramen ovale (PFO) closure lies in successfully establishing an occlusion pathway through the PFO tunnel using a guidewire or catheter. In this study, we aim to investigate the efficacy and safety of Swartz sheath with angioplasty guidewire-assisted technique for PFO Closure.

Eligibility

Age: 18 Years – 65 YearsHealthy volunteers accepted
Inclusion Criteria:

* Aged between 18 and 65
* Confirmed diagnosis of PFO by transthoracic and transesophageal echocardiography
* A history of cryptogenic stroke (CS) or transient ischemic attack (TIA)

Exclusion Criteria:

* Confirmed pregnancy
* Confirmed diagnosis of intracardiac thrombosis
* Confirmed diagnosis of pulmonary hypertension
* Confirmed diagnosis of rheumatic heart disease, or valvular heart disease
* Past medical history of myocardial infarction, unstable angina and intracranial hemorrhage

Conditions2

Heart DiseasePatent Oval Foramen

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