Clinical Trial

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

Recruiting
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Record status
This record was last updated November 21, 2024 (before its estimated March 31, 2025 completion). Its status may not reflect the trial's current state.
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)
Trial Details
NCT Number NCT06700174
Lead Sponsor Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions Atrial Septal Defect (ASD)
Enrollment 100 participants
Start Date 2024-09-24
Primary Completion 2025-03-31 (estimated)
Study Completion 2025-03-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-21