Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study
A Multicenter, Prospective, Single-arm, Observational Study
1 other identifier
observational
100
1 country
5
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2024
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 24, 2024
CompletedFirst Submitted
Initial submission to the registry
November 15, 2024
CompletedFirst Posted
Study publicly available on registry
November 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedNovember 21, 2024
November 1, 2024
6 months
November 15, 2024
November 19, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (4)
Device success rate
At procedure
Incidence of procedure and/or device-related complications
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
Eligibility Criteria
Patients with echocardiographic confirmation of a single secundum atrial septal defect (ASD) who are scheduled to undergo ASD closure.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2024
First Posted
November 21, 2024
Study Start
September 24, 2024
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
November 21, 2024
Record last verified: 2024-11