Technique for closing a hole in the heart
Official title: Swartz Sheath With Angioplasty Guidewire-Assisted Versus Conventional Technique for Patent Foramen Ovale Closure: A Multicenter Randomized Controlled Trial
Run by RenJi Hospital · NCT06793969 · Data updated 2026-11-12
This study is testing a new way to close a hole in the heart using a special tool to see if it works better and is safer than the usual method for patients who have had a stroke or mini-stroke.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | December 24, 2023 |
| Main results expected | March 30, 2025 |
| Study ends | May 30, 2025 |
| Registry record updated | January 27, 2025 |
| Trial ID | NCT06793969 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 65 with a confirmed diagnosis of PFO and a history of cryptogenic stroke or transient ischemic attack.
✕Probably not a fit
Patients with conditions such as pregnancy, intracardiac thrombosis, pulmonary hypertension, or significant heart disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates a new technique using a Swartz sheath with an angioplasty guidewire to assist in closing a patent foramen ovale (PFO) in patients who have experienced a cryptogenic stroke or transient ischemic attack. It is a multicenter, prospective, randomized controlled trial that compares this novel approach to a conventional method using a multifunctional catheter. Patients will be randomly assigned to either the new technique group or the conventional group, and various safety parameters will be monitored throughout the procedure and during follow-up visits. The aim is to evaluate the efficacy and safety of this new technique in facilitating PFO closure.
Why it matters
Potential benefit: If successful, this technique could improve the safety and efficacy of PFO closure procedures, potentially reducing the risk of future strokes in patients.
How similar studies have gone: While similar techniques have been explored, this specific approach using the Swartz sheath with angioplasty guidewire is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Renji Hospital
Shanghai, China Recruiting
Study contacts
- Study coordinator: ZHIGUO ZOU, MD, PhD
- Email: zouzhiguo@renji.com
- Phone: +86 13524596108
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.