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

NCT06793969 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-01-27

No results posted yet for this study

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.

Conditions

  • Patent Oval Foramen

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sheath for the PFO closure device is introduced to the left atrium along the guidewire, and all other toolkits are withdrawn.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

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-24
Primary Completion
2025-03-30
Completion
2025-05-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06793969 on ClinicalTrials.gov