Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD
NCT ID: NCT04591392
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
250 participants
INTERVENTIONAL
2021-03-12
2032-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Device
ASD closure with the reSept ASD Occluder
reSept ASD Occluder
Transcatheter closure of secundum ASD using a permanent implant
Interventions
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reSept ASD Occluder
Transcatheter closure of secundum ASD using a permanent implant
Eligibility Criteria
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Inclusion Criteria
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.
10. Capable of giving informed consent, or, for minors, consent of the parent or legal guardian, and willing to comply with the clinical investigation requirements.
Exclusion Criteria
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.
10. Known allergy to investigational device components or medications, or other contraindication to clinical investigation medications (acetylsalicylic acid, heparin), including a documented history of bleeding, clotting or coagulation disorders, untreated ulcer or any other contraindications to acetylsalicylic acid or antiplatelet therapy.
11. Known hypercoagulable state.
12. Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation as well as any severe concurrent illness that would limit life expectancy (e.g. malignancies).
13. Currently an active subject in an investigational drug or device study that could confound the results of this study.
14. Patients who, in the opinion of the investigator, are inappropriate for inclusion into this clinical investigation or will not comply with requirements of the clinical investigation.
15. Are known to abuse drugs or alcohol.
16. Patients with the diagnosis of Patent Foramen Ovale (PFO).
84 Years
ALL
No
Sponsors
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atHeart Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Forbes, MD
Role: PRINCIPAL_INVESTIGATOR
Joe DiMaggio Children's Hospital/Memorial Healthcare
Saibal Kar, MD
Role: PRINCIPAL_INVESTIGATOR
Los Robles Regional Medical Center
Locations
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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
University of Michigan
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mount Sinai Medical Center
New York, New York, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Toronto General Hospital
Toronto, , Canada
Hôpital cardiologique Haut-Leveque (CHU Bordeaux)
Bordeaux, , France
Service de Cardiologie Pédiatrique et Congénitale
Lille, , France
Hôpital Mere Enfants (CHU Nantes)
Nantes, , France
Hôpital Necker Enfants Malades
Paris, , France
Hôpital des Enfants (CHU Toulouse)
Toulouse, , France
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, , Switzerland
University Children's Hospital Zurich
Zurich, , Switzerland
Countries
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Other Identifiers
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008-022
Identifier Type: -
Identifier Source: org_study_id
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