Technique for closing a hole in the heart
Swartz Sheath With Angioplasty Guidewire-Assisted Versus Conventional Technique for Patent Foramen Ovale Closure: A Multicenter Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06793969 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with conditions such as pregnancy, intracardiac thrombosis, pulmonary hypertension, or significant heart disease may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai
- Renji Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: ZHIGUO ZOU, MD, PhD
- Email: zouzhiguo@renji.com
- Phone: +86 13524596108
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.