Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD (ASCENT ASD)
- Study HIC#:2000029209
- Last Updated:04/21/2023
Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect.
- Age84 years and younger
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Amanda Catucci
- Phone Number: 1-203-785-6947
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Trial Purpose and 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 Criteria
Inclusion Criteria:
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 4 to 19 mm on screening diagnostic echocardiogram.
- Isolated secundum ASD of size 4 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/defect margins to support the device. The rim is considered adequate unless it measures less than 5mm over an entire 45 degree segment.
- 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:
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).