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

Swartz Sheath With Angioplasty Guidewire-Assisted Versus Conventional Technique for Patent Foramen Ovale Closure: A Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Patent Oval Foramen
• Intervention / Treatment: Procedure: Conventional technique to pass the PFO tunnel; Procedure: Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ZHIGUO ZOU, MD, PhD; Phone Number: +86 13524596108; Email: zouzhiguo@renji.com

Study Locations

• China
  • Shanghai, China, 200127
    • Recruiting
    • RenJi Hospital
    • Contact: ZHIGUO ZOU, MD, PhD; Phone Number: +86 13524596108; Email: zouzhiguo@renji.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Procedure: Conventional technique to pass the PFO tunnel; In the conventional group, the PFO closure procedure is performed with a multi-functional catheter and guided by intraprocedural fluoroscopy and 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.	Procedure: Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage; The angioplasty guidewire is advanced into the left atrium and left superior pulmonary vein (LSPV). The Swartz sheath is then delivered to the left atrium along the 0.014" guidewire through the PFO. Next, the Runthrough guidewire is changed to a 0.035" J-tipped guidewire, which is advanced into the LSPV. Finally, the delivery sheath for the PFO closure device is introduced to the left atrium along the guidewire, and all other toolkits are withdrawn.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of PFO tunnel passage	The total time required to pass the guide across PFO tunnel	Intraprocedural assessment (measured in minutes )

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2023
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Septal Defects, Atrial; Heart Septal Defects; Foramen Ovale, Patent
• Other Study ID Numbers: STAGE-PFO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No