Clinical trial NCT06793969: Swartz Sheath With Angioplasty Guidewire-Assisted Technique for Patent Foramen Ovale Closure (STAGE-PFO)
Official title: Swartz Sheath With Angioplasty Guidewire-Assisted Versus Conventional Technique for Patent Foramen Ovale Closure: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patent Oval Foramen
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time of PFO tunnel passage
timeFrame: Intraprocedural assessment (measured in minutes )
Secondary outcomes:
measure: Procedure Time
timeFrame: Intraprocedural assessment (measured in minutes )
measure: Fluoroscopy Time
timeFrame: Intraprocedural assessment (measured in minutes )
measure: Procedural Complications
timeFrame: Intraprocedural assessment
measure: Radiation Dose
timeFrame: Intraprocedural assessment (measured in mGys)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
References: