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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Patent Oval Foramen

Treatments: Procedure: Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage; Procedure: Conventional technique to pass the PFO tunnel

Study type: Interventional

Funder types: Other

Identifiers

NCT06793969

STAGE-PFO

Details and patient eligibility

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

The conventional group

Sham Comparator group

Description:

In the conventional group, the PFO closure procedure is performed with a multi-functional catheter and guided by intraprocedural fluoroscopy and intracardiac echocardiography (ICE).

Treatment:

Procedure: Conventional technique to pass the PFO tunnel

The Swartz sheath + angioplasty guidewire group

Active Comparator group

Description:

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.

Treatment:

Procedure: Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage