Atrial Septal Defect (ASD)
Conditions
Brief summary
The objective of this PMCF study is to: * confirm the safety and performance of the AcuMarkTM Sizing Balloon * identify previously unknown side-effects * monitor the identified side-effects (related to the procedure or to the medical devices)
Interventions
None listed
Sponsors
Lifetech Scientific (Shenzhen) Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sizing success rate | At procedure | The size of the selected occluder is proper by echocardiography observing |
| Incidence of major adverse events (MAEs) | From attempted procedure to discharge, up to 14 days | Major adverse events are defined as stroke, occluder embolization, arrhythmia, thromboembolic event, oversizing of the defect, cardiac tamponade, and other procedure and/or device-related complications requiring re-intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device success rate | At procedure | Study device is successfully delivered in place and dilated without rupture and is successfully withdrew. |
| Incidence of procedure and/or device-related complications | From attempted procedure to discharge, up to 14 days | Complications include vessel perforation/dissection, thromboembolism, hematoma, arrythmia, expansion of the defect, balloon migration, obstruction of venous return from the inferior vena cava. |
| Incidence of Serious Adverse Events | From attempted procedure to discharge, up to 14 days | — |
| Incidence of Device Deficiency (DD) | From attempted procedure to discharge, up to 14 days | — |
Countries
Turkey (Türkiye)
Contacts
Primary ContactShen Yuanyuan
Backup ContactFu Jiaxuan
Outcome results
None listed