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

Not Applicable

Recruiting

• Conditions: Patent Oval Foramen

• Registration Number: NCT06793969
• Lead Sponsor: RenJi Hospital

Brief 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.

Detailed Description

In cases of complex PFO, failure of guidewire passage through the septum can occur, rendering closure impossible. The present multicenter, prospective, randomized controlled trial aims to evaluate the efficacy and safety of a novel Swartz sheath with angioplasty guidewire-assisted technique to facilitate PFO tunnel passage.

With written consent, the investigators expect to enrol PFO patients with a history of cryptogenic stroke (CS) or transient ischemic attack (TIA), who requires PFO closure according to current guidelines. A standardized TEE protocol is used to assess the morphologic characteristics of the atrial septum and right-to-left shunting through PFO. Eligible patients are prospectively and randomly assigned to the Swartz sheath + angioplasty guidewire group or the conventional group (1:1 ratio). In the Swartz sheath + angioplasty guidewire group, the PFO closure procedure is performed with Swartz sheath + angioplasty guidewire assistance. In the conventional group, the PFO closure procedure is performed with a multi-functional catheter. After the procedure, safety parameters such as contrast use, procedure time, and severe complications are recorded. All patients are followed up at 1-, 3-, 6-, and 12- month post device implantation. The presence of a residual shunt, device embolization, device migration and residual shunt are recorded.

Study Timeline

• Study Start: 2023-12-24
• Status Verified: 2025-01
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-03-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time of PFO tunnel passage	Intraprocedural assessment (measured in minutes )	The total time required to pass the guide across PFO tunnel

Secondary Outcome Measures

Name	Time	Method
Procedure Time	Intraprocedural assessment (measured in minutes )	The total time required to complete PFO closcure
Fluoroscopy Time	Intraprocedural assessment (measured in minutes )	The total fluoroscopy time during the procedure
Procedural Complications	Intraprocedural assessment	Complications such as inguinal haematoma and pericardial effusion related to the PFO closure procedure
Radiation Dose	Intraprocedural assessment (measured in mGys)	The total dosage of radiation required to complete the PFO closure procedure

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, China