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

Running, not enrolling · Not applicable

Conditions studied: Heart Septal Defect, Heart Septal Defects, Atrial, Heart Defects, Congenital, Cardiovascular Abnormalities, Cardiovascular Diseases, Heart Diseases, Congenital Abnormalities

In brief

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

Key facts

Study ID

NCT04591392

Run by

atHeart Medical

People needed

250

Starts

2021-03-12

Expected to finish

2032-03-01

Last updated by the study team

2025-05-07

Who can join

Age: any, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All responses must be Yes to be eligible:
• Age < 85 years.
• Body weight ≥ 15 kg / 33 lb.
• Males and Females.
• 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.
• ASD of size 5 to 19 mm on screening diagnostic echocardiogram.
• Isolated secundum ASD of size 8 to 22 mm on stop flow balloon diameter, based upon echocardiographic and fluoroscopic evidence obtained at procedure.
• 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.
• 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
• 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.
• Capable of giving informed consent, or, for minors, consent of the parent or legal guardian, and willing to comply with the clinical investigation requirements.

You may not qualify if…

• All responses must be No to be eligible:
• 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.
• Any significant valve dysfunction that contraindicates ASD closure, or increased pulmonary vascular resistance/severe pulmonary hypertension.
• 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.
• Subjects having undergone left sided structural heart interventions performed via transseptal access (e.g. Mitraclip, LAAO, percutaneous mitral valve replacement).
• Evidence of thrombus in the left atrium, left atrial appendage, other cardiac chamber, or the inferior vena cava.
• Sepsis or any other infection that was not successfully treated at least 30 days prior to device placement.
• Active endocarditis or other infection(s) producing bacteremia.
• History of atrial tachycardia, atrial fibrillation or flutter, AV block, or ventricular arrhythmia requiring antiarrhythmic medication, pacemaker or AICD.
• Vasculature is of inadequate size to accommodate all procedural instrumentation.
• 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.
• Known hypercoagulable state.
• 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).
• Currently an active subject in an investigational drug or device study that could confound the results of this study.
• 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.
• Are known to abuse drugs or alcohol.
• Patients with the diagnosis of Patent Foramen Ovale (PFO).

Where it is running

• 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

Full record on ClinicalTrials.gov

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