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

Recruiting now · Not applicable

Conditions studied: Patent Oval Foramen

In brief

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.

Key facts

Study ID

NCT06793969

Run by

RenJi Hospital

People needed

120

Starts

2023-12-24

Expected to finish

2025-05-30

Last updated by the study team

2025-01-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Renji Hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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