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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLifetech Scientific (Shenzhen) Co., Ltd.

About this trial

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)

Eligibility criteria

Qualifiers

Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography;

The anatomy of ASD is suitable for percutaneous closure;

Patients are scheduled to perform ASD closure;

Patients or legally authorized representative(s) who are willing and capable of providing informed consent.

Disqualifiers

Any contraindication for ASD closure;

Patients have ostium primum ASD or coronary sinus ASD;

Patients who are pregnant or breastfeeding;

Patient is currently participating in another clinical trial that has not yet completed its primary endpoint.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed