Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study
Recruiting
Observational Study
Atrial Septal Defect (ASD)
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Sex
- Any
- Study type
- Observational
- Participants needed
- 100 (estimated)
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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)
Trial Locations
Loading…
Loading trial locations…
Eligibility 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 will…
Contacts