NCT06700174RecruitingNot Applicable
A Multicenter, Prospective, Single-arm, Observational Study
Lifetech Scientific (Shenzhen) Co., Ltd.5 sites in 1 country100 target enrollmentStarted: September 24, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 5
- Primary Endpoint
- Sizing success rate
Study Overview
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)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Sizing success rate
Time Frame: At procedure
The size of the selected occluder is proper by echocardiography observing
Incidence of major adverse events (MAEs)
Time Frame: 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 Outcomes
- 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)
Investigators
Study Sites (5)
Loading locations...
Similar Trials
Completed
Not Applicable
Safety and Performance of ENTACT Septal Staple System for SeptoplastySeptoplastyNCT04392583Smith & Nephew, Inc.40
Terminated
Not Applicable
A PMCF Investigation on Chronic LU and DFU in Need of Debridement With ChloraSolv®Chronic Leg UlcerChronic Diabetic Foot UlcerNCT04838600RLS Global34
Completed
Not Applicable
Confirmatory Study: Assessing the Efficacy and Safety of the AcusMu Microneedle Patch in Treating Periorbital WrinklesWrinkleNCT06158867AcusMu Medtech Co., Ltd.12
Active, not recruiting
Not Applicable
Clinical Investigation of the da Vinci Surgical SystemThymomaMediastinal TumorGynecologic DiseaseGynecologic CancerPelvic Organ ProlapseProstate DiseaseVentral HerniaObesity, MorbidProstate CancerInguinal HerniaNCT05682742Intuitive Surgical53
Completed
Not Applicable
AVJ-514 Japan TrialMitral InsufficiencyMitral Stenosis With InsufficiencyFunctional Mitral RegurgitationMitral Valve IncompetenceMitral Valve RegurgitationNCT02520310Abbott Medical Devices30