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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Study First Submitted
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
(from sponsor)		 Atrial Septal Defect (ASD)
Related terms Heart Septal Defects, Atrial
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov