Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD (ASCENT ASD)

  • STATUS
    Recruiting
  • End date
    Sep 16, 2027
  • participants needed
    250
  • sponsor
    atHeart Medical
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Updated on 16 May 2022
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aspirin

Summary

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

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.

Details
Condition Heart Septal Defect, Heart Septal Defects, Atrial, Heart Defects, Congenital, Cardiovascular Abnormalities, Cardiovascular Diseases, Heart Diseases, Congenital Abnormalities
Treatment reSept ASD Occluder
Clinical Study IdentifierNCT04591392
SponsoratHeart Medical
Last Modified on16 May 2022

Eligibility

 Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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