RecruitingNCT06700174
Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study
A Multicenter, Prospective, Single-arm, Observational Study
Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
Enrollment
100 participants
Start Date
Sep 24, 2024
Study Type
OBSERVATIONAL
Conditions
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)
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria4
- 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.
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Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06700174