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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04591392
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : November 18, 2022
Sponsor:
Information provided by (Responsible Party):
atHeart Medical

Study Description
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Brief Summary:
Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect

Condition or disease Intervention/treatment Phase
Heart Septal Defect Heart Septal Defects, Atrial Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities Device: reSept ASD Occluder Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of the reSept ASD Occluder to Treat Patients With Clinically Significant Secundum Atrial Septal Defect
Actual Study Start Date : March 12, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Device
ASD closure with the reSept ASD Occluder
 Device: reSept ASD Occluder
Transcatheter closure of secundum ASD using a permanent implant


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects with 12-Month Composite Clinical Success [ Time Frame: 12 months ]
    1. Clinically effective ASD closure, defined as no residual ASD or clinically insignificant residual ASD as determined by core laboratory review; and
    2. No re-intervention to treat the defect; and
    3. No device or procedure related serious adverse event.

  2. Number of Subjects with CEC adjudicated Device- or Procedure-related SAEs [ Time Frame: 12 months ]
    Incidence of subjects experiencing one or more serious device- or procedure related adverse events through the 12 month follow up visit, as adjudicated by the Clinical Events Committee (CEC)


Secondary Outcome Measures :
  1. ASD Closure Success among Technical Success Subjects [ Time Frame: 1 month, 6 months and 12 months ]
    Assessment of device performance will include closure success, among subjects that were technical successes (i.e. successful placement and release of the reSept ASD Occluder at the ASD), defined as no residual ASD or clinically insignificant residual ASD determined by echocardiography. Assessment of closure success at each follow up through the 12-month follow up will be assessed by TTE.

  2. Number of Subjects with Device- or Procedure-related AEs [ Time Frame: 12 months ]
    Incidence of subjects experiencing one or more non serious device- or procedure-related adverse events through the 12-month follow up visit.


Eligibility Criteria
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Ages Eligible for Study:   up to 84 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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:

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.
  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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04591392


Contacts
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Contact: Brandi Sadowski +1 408-412-7245 b.sadowski@atheartmedical.com

Locations
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Sponsors and Collaborators
atHeart Medical
Investigators
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Principal Investigator: Larry Latson, MD Joe DiMaggio Children's Hospital/Memorial Healthcare
Principal Investigator: Saibal Kar, MD Los Robles Regional Medical Center
More Information
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Responsible Party: atHeart Medical
ClinicalTrials.gov Identifier: NCT04591392    
Other Study ID Numbers: 008-022
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: November 18, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Heart Septal Defects
Heart Defects, Congenital
 Cardiovascular Abnormalities
Heart Septal Defects, Atrial
Congenital Abnormalities