Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study

LifeTech Scientific

Status: Enrolling

Conditions: Atrial Septal Defect (ASD)

Study type: Observational

Funder types: Industry

Identifiers

NCT06700174

LT/TS/571I-2023

Details and patient eligibility

About

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)

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.