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Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD | Clinical Trials | Clareo Health

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Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD

Evaluation of the Safety and Efficacy of the reSept ASD Occluder to Treat Patients With Clinically Significant Secundum Atrial Septal Defect

NCT04591392•atHeart Medical

View on ClinicalTrials.gov

Summary

Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect

Detailed Description

Prospective, three-stage, single arm, multi-site, clinical investigation evaluating the safety and efficacy of the reSept ASD Occluder in treating clinically significant secundum ASD. Outcomes/endpoints of the clinical investigation will be compared with established performance goals for FDA approved transcatheter secundum ASD occluders.

Eligibility

Age

0 - 84 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All responses must be Yes to be eligible:
•1. Age \< 85 years.
•2. Body weight ≥ 15 kg / 33 lb.
•3. Males and Females.
•4. Clinically significant, isolated secundum ASD associated with a L-R shunt and signs of RV volume overload that, based upon the expertise of attending physicians requires treatment.
•5. ASD of size 5 to 19 mm on screening diagnostic echocardiogram.
•6. Isolated secundum ASD of size 8 to 22 mm on stop flow balloon diameter, based upon echocardiographic and fluoroscopic evidence obtained at procedure.
•7. Able to take required medications: ASA (Aspirin), low dose (75-100 mg/day), 24 hours prior to and for 6 months following the procedure; Heparin intra-procedurally.
•8. Adequate septal rim to support the device. The rim is considered inadequate if it measures less than 5mm in more than two views of a critical structure
•9. Adequate defect margin to safely accommodate the selected size implant without interfering with adjacent cardiac structures (e.g., aorta, AV valves, ostia of the pulmonary veins, coronary sinus, or other critical structures), based on the IFU sizing guidance.
+1 more criteria

Exclusion Criteria

•All responses must be No to be eligible:
•1. Pregnancy. Females with child-bearing potential are required to be tested for pregnancy prior to treatment, in accordance with the local institution's policy. For minor females, a pregnancy test will be done in accordance with the local institution's policy.
•2. Any significant valve dysfunction that contraindicates ASD closure, or increased pulmonary vascular resistance/severe pulmonary hypertension.
•3. Acquired pathological or congenital abnormalities of the cardiovascular system (other than isolated secundum ASD; e.g. congenital malformations, calcification, myocardial infarction, intracardiac thrombi, dilated cardiomyopathy, untreated coronary disease or CAD treated with a stent in the prior 12 months) being clinically significant, that would interfere with the conduct of the clinical investigation.
•4. Subjects having undergone left sided structural heart interventions performed via transseptal access (e.g. Mitraclip, LAAO, percutaneous mitral valve replacement).
•5. Evidence of thrombus in the left atrium, left atrial appendage, other cardiac chamber, or the inferior vena cava.
•6. Sepsis or any other infection that was not successfully treated at least 30 days prior to device placement.
•7. Active endocarditis or other infection(s) producing bacteremia.
•8. History of atrial tachycardia, atrial fibrillation or flutter, AV block, or ventricular arrhythmia requiring antiarrhythmic medication, pacemaker or AICD.
•9. Vasculature is of inadequate size to accommodate all procedural instrumentation.
+7 more criteria

Locations (32)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

Los Robles Regional Medical Center

Thousand Oaks, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

Joe DiMaggio Children's Hospital/Memorial Healthcare System

Hollywood, Florida, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Advocate Children's Hospital

Oak Lawn, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

March 12, 2021

Primary Completion Date

March 1, 2027

Completion Date

March 1, 2032

Last Updated

May 7, 2025

Enrollment

250

ESTIMATED participants

Conditions

Heart Septal DefectHeart Septal Defects, AtrialHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital Abnormalities

Interventions

reSept ASD Occluder

DEVICE

Congenital Heart Disease Physical Activity Lifestyle Study V.2

NCT06003023

Heart Defects, CongenitalCardiovascular Disease Other

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ENROLLING_BY_INVITATION

Global Utilization And Registry Database for Improved heArt preservatioN

NCT04141605

Heart DiseasesHeart Failure+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD

Inclusion Criteria

Exclusion Criteria

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