Follow-up on the AcuMark Sizing Balloon for heart defect treatment
A Multicenter, Prospective, Single-arm, Observational Study
This study is testing the safety and effectiveness of the AcuMark Sizing Balloon for closing heart defects in patients with a specific type of ASD.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Lifetech Scientific (Shenzhen) Co., Ltd. Industry-sponsored |
| Locations | 5 sites (Ankara and 4 other locations) |
| Trial ID | NCT06700174 on ClinicalTrials.gov |
What this trial studies
This observational study aims to confirm the safety and performance of the AcuMark Sizing Balloon used in the closure of atrial septal defects (ASD). It will monitor patients who have been diagnosed with a single secundum ASD and are scheduled for closure procedures. The study will also identify and track any previously unknown side effects related to the device or the procedure itself. By gathering this data, the study seeks to enhance the understanding of the device's impact on patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with a single secundum ASD who are scheduled for closure and can provide informed consent.
Not a fit: Patients with contraindications for ASD closure or those with specific types of ASD, such as ostium primum or coronary sinus ASD, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and effectiveness of ASD closure procedures for patients.
How similar studies have performed: While this study focuses on post-market follow-up, similar studies have shown success in monitoring device performance and safety, indicating a potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography; 2. The anatomy of ASD is suitable for percutaneous closure; 3. Patients are scheduled to perform ASD closure; 4. Patients or legally authorized representative(s) who are willing and capable of providing informed consent. Exclusion Criteria: 1. Any contraindication for ASD closure; 2. Patients have ostium primum ASD or coronary sinus ASD; 3. Patients who are pregnant or breastfeeding; 4. Patient is currently participating in another clinical trial that has not yet completed its primary endpoint.
Where this trial is running
Ankara and 4 other locations
- Ankara (Bilkent) City Hospital — Ankara, Turkey (Türkiye) (Recruiting)
- Gazi Yasargil Woman and Child Hospital — Diyarbakır, Turkey (Türkiye) (Recruiting)
- Gaziantep University Hospital — Gaziantep, Turkey (Türkiye) (Not_yet_recruiting)
- SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital — Istanbul, Turkey (Türkiye) (Not_yet_recruiting)
- Tepecik Training and Research Hospital — Izmir, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Shen Yuanyuan
- Email: shenyuanyuan@lifetechmed.com
- Phone: 86+18504356312
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.