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

December 21, 2023 updated by: atHeart Medical

Evaluation of the Safety and Efficacy of the reSept ASD Occluder to Treat Patients With Clinically Significant Secundum Atrial Septal Defect

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital of Los Angeles
        • Principal Investigator:
          • Darren Berman, MD
        • Contact:
      • Thousand Oaks, California, United States, 91360
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Jeremy Asnes, MD
    • Florida
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Joe DiMaggio Children's Hospital/Memorial Healthcare System
        • Principal Investigator:
          • Larry Latson, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Children's Healthcare of Atlanta
        • Contact:
        • Principal Investigator:
          • Dennis Kim, MD
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Advocate Children's Hospital
        • Contact:
        • Principal Investigator:
          • Alexander Javois, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children
        • Contact:
        • Principal Investigator:
          • Michael Ross, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Jeffrey Zampi, MD
      • Detroit, Michigan, United States, 48202
        • Active, not recruiting
        • Children's Hospital of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • David Balzer, MD
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Medical Center
        • Principal Investigator:
          • Barry Love, MD
        • Contact:
      • New York, New York, United States, 10032
        • Withdrawn
        • Columbia University Medical Center/NYPH
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital
        • Principal Investigator:
          • Shabana Shahanavaz, MD
        • Contact:
      • Columbus, Ohio, United States, 43215
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Matthew Gillespie, MD
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • UPMC Children's Hospital of Pittsburgh
        • Contact:
        • Principal Investigator:
          • Bryan Goldstein, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • John Rhodes, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75230
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
        • Principal Investigator:
          • Srinath Gowda, MD
    • Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Principal Investigator:
          • Scott Lim, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 84 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month, 6 months and 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

atHeart Medical

Investigators

  • Principal Investigator: Saibal Kar, MD, Los Robles Regional Medical Center
  • Principal Investigator: Larry Latson, MD, Joe DiMaggio Children's Hospital/Memorial Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

October 12, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 008-022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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