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

Recruiting

• Conditions: Atrial Septal Defect (ASD)

• Registration Number: NCT06700174
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-24
• Status Verified: 2024-11
• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Device success rate	At procedure	Study device is successfully delivered in place and dilated without rupture and is successfully withdrew.
Incidence of procedure and/or device-related complications	From attempted procedure to discharge, up to 14 days	Complications include vessel perforation/dissection, thromboembolism, hematoma, arrythmia, expansion of the defect, balloon migration, obstruction of venous return from the inferior vena cava.
Incidence of Serious Adverse Events	From attempted procedure to discharge, up to 14 days
Incidence of Device Deficiency (DD)	From attempted procedure to discharge, up to 14 days

Trial Locations

Locations (5)

Ankara (Bilkent) City Hospital; 🇹🇷 Ankara, Turkey

Gazi Yasargil Woman and Child Hospital; 🇹🇷 Diyarbakir, Turkey

Gaziantep University Hospital; 🇹🇷 Gaziantep, Turkey

SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Tepecik Training and Research Hospital; 🇹🇷 Izmir, Turkey