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Clinical Trial NCT06700174 for Atrial Septal Defect (ASD) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study 100 Medical Device
Clinical Trial NCT06700174 is an observational study for Atrial Septal Defect (ASD) that is recruiting. It started on 24 September 2024 with plans to enroll 100 participants. Led by Lifetech Scientific (Shenzhen) Co., Ltd., it is expected to complete by 31 March 2025. The latest data from ClinicalTrials.gov was last updated on 21 November 2024.
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)
Official Title
A Multicenter, Prospective, Single-arm, Observational Study
Conditions
Atrial Septal Defect (ASD)Other Study IDs
- LT/TS/571I-2023
NCT ID Number
Start Date (Actual)
2024-09-24
Last Update Posted
2024-11-21
Completion Date (Estimated)
2025-03-31
Enrollment (Estimated)
100
Study Type
Observational
Status
Recruiting
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Sizing success rate | The size of the selected occluder is proper by echocardiography observing | At procedure |
Incidence of major adverse events (MAEs) | 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. | From attempted procedure to discharge, up to 14 days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Device success rate | Study device is successfully delivered in place and dilated without rupture and is successfully withdrew. | At procedure |
Incidence of procedure and/or device-related complications | Complications include vessel perforation/dissection, thromboembolism, hematoma, arrythmia, expansion of the defect, balloon migration, obstruction of venous return from the inferior vena cava. | From attempted procedure to discharge, up to 14 days |
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
- Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography;
- The anatomy of ASD is suitable for percutaneous closure;
- Patients are scheduled to perform ASD closure;
- Patients or legally authorized representative(s) who are willing and capable of providing informed consent.
- Any contraindication for ASD closure;
- Patients have ostium primum ASD or coronary sinus ASD;
- Patients who are pregnant or breastfeeding;
- Patient is currently participating in another clinical trial that has not yet completed its primary endpoint.
Lifetech Scientific (Shenzhen) Co., Ltd.Study Central Contact
Contact: Shen Yuanyuan, 86+18504356312, [email protected]
Contact: Fu Jiaxuan, 86 13973207184, [email protected]
5 Study Locations in 1 Countries
Ankara (Bilkent) City Hospital, Ankara, Turkey (Türkiye)
ECE Ibrahim, Contact, [email protected]
ECE Ibrahim, Contact
Recruiting
Gazi Yasargil Woman and Child Hospital, Diyarbakır, Turkey (Türkiye)
ALDUDAK Bedri, Contact, [email protected]
ALDUDAK Bedri, Contact
Recruiting
Gaziantep University Hospital, Gaziantep, Turkey (Türkiye)
BASPINAR Osman, Contact, [email protected]
BASPINAR Osman, Contact
Not yet recruiting
SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey (Türkiye)
DEMIR Halil Ibrahim, Contact, [email protected]
DEMIR Halil Ibrahim, Contact
Not yet recruiting
Tepecik Training and Research Hospital, Izmir, Turkey (Türkiye)
NARIN Nazmi, Contact, [email protected]
NARIN Nazmi, Contact
Recruiting