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

NCT06700174 · tracked via the Priya Life Science Turkey tracker

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd

Phase

Observational

Started

2024-09-24

Last updated

2024-11-21

Condition(s) studied

Atrial Septal Defect (ASD)

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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 willing and capable of providing informed consent. Exclusion Criteria: 1. Any contraindication for ASD closure; 2. Patients have ostium primum ASD or coronary sinus ASD; 3. Patients who are pregnant or breastfeeding; 4. Patient is currently participating in another clinical trial that has not yet completed its primary endpoint.

Primary outcome measure(s)

Sizing success rate — At procedure
The size of the selected occluder is proper by echocardiography observing
Incidence of major adverse events (MAEs) — From attempted procedure to discharge, up to 14 days
Major adverse events are defined as stroke, occluder embolization, arrhythmia, thromboembolic event, oversizing of the defect, cardiac tamponade, and other procedure and/or device-related complications requiring re-intervention.

Trial sites (5)

Facility	City	Region	Status
Ankara (Bilkent) City Hospital	Ankara	Turkey (Türkiye)	Recruiting
Gazi Yasargil Woman and Child Hospital	Diyarbakır	Turkey (Türkiye)	Recruiting
Gaziantep University Hospital	Gaziantep	Turkey (Türkiye)	Not Yet Recruiting
SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital	Istanbul	Turkey (Türkiye)	Not Yet Recruiting
Tepecik Training and Research Hospital	Izmir	Turkey (Türkiye)	Recruiting

More Lifetech Scientific (Shenzhen) Co., Ltd. trials in Turkey

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Cera™ Vascular Plug System Post-Market Clinical Follow-Up Recruiting

Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06700174 on ClinicalTrials.gov ↗ ← All trials in Turkey