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

Atrial Septal Defect (ASD)

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with atrial septal defect (asd). The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(5)

Ankara (Bilkent) City Hospital

Ankara, Turkey (Türkiye)

Gazi Yasargil Woman and Child Hospital

Diyarbakır, Turkey (Türkiye)

Gaziantep University Hospital

Gaziantep, Turkey (Türkiye)

SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital

Istanbul, Turkey (Türkiye)

Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT06700174

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