Swartz Sheath With Angioplasty Guidewire-Assisted Versus Conventional Technique for Patent Foramen Ovale Closure: A Multicenter Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
China
Renji Hospital
RECRUITING
Shanghai
Contact Information
Primary
ZHIGUO ZOU, MD, PhD
zouzhiguo@renji.com
+86 13524596108
Time Frame
Start Date: 2023-12-24
Estimated Completion Date: 2025-05-30
Participants
Target number of participants: 120
Treatments
Sham_comparator: The conventional group
In the conventional group, the PFO closure procedure is performed with a multi-functional catheter and guided by intraprocedural fluoroscopy and intracardiac echocardiography (ICE).
Active_comparator: The Swartz sheath + angioplasty guidewire group
In the Swartz sheath + angioplasty guidewire group, the PFO closure procedure is performed with Swartz sheath + angioplasty guidewire assistance and guided by intraprocedural fluoroscopy and ICE.
Related Therapeutic Areas
Sponsors
Leads: RenJi Hospital