Swartz Sheath With Angioplasty Guidewire-Assisted Technique for Patent Foramen Ovale Closure (STAGE-PFO)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage, Conventional technique to pass the PFO tunnel.
- Who it may be relevant to
- Registry conditions: Patent Oval Foramen. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Swartz Sheath With Angioplasty Guidewire-Assisted Versus Conventional Technique for Patent Foramen Ovale Closure: A Multicenter Randomized Controlled Trial
Overview
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.
Interventions
- 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. - 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
Primary outcome measures
- Time of PFO tunnel passage [Time frame: Intraprocedural assessment (measured in minutes )]
Secondary outcome measures (4)
- Procedure Time [Time frame: Intraprocedural assessment (measured in minutes )]
- Fluoroscopy Time [Time frame: Intraprocedural assessment (measured in minutes )]
- Procedural Complications [Time frame: Intraprocedural assessment]
- Radiation Dose [Time frame: Intraprocedural assessment (measured in mGys)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Renji Hospital — Shanghai
Identifiers
NCT: NCT06793969 · STAGE-PFO