Actively Recruiting
Swartz Sheath With Angioplasty Guidewire-Assisted Technique for Patent Foramen Ovale Closure (STAGE-PFO)
Led by RenJi Hospital · Updated on 2025-01-27
120
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Swartz Sheath With Angioplasty Guidewire-Assisted Technique for Patent Foramen Ovale Closure (STAGE-PFO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Renji Hospital
Shanghai, China, 200127
Actively Recruiting
Research Team
Z
ZHIGUO ZOU, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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