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

NCT04591392 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 008-022
• Study Type: interventional
• Target: 250
• Locations: 4 countries
• Sites: 32

Brief Summary

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

Conditions

Heart Septal Defect; Heart Septal Defects, Atrial; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities

Outcome Measures

Primary Outcomes (2)

• Number of Subjects with 12-Month Composite Clinical Success

  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

  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 Outcomes (2)

• ASD Closure Success among Technical Success Subjects

  1 month, 6 months and 12 months

• Number of Subjects with Device- or Procedure-related AEs

  12 months

Study Arms (1)

Device

EXPERIMENTAL

ASD closure with the reSept ASD Occluder

Device: reSept ASD Occluder

Interventions

reSept ASD Occluder DEVICE

Transcatheter closure of secundum ASD using a permanent implant

Device

Eligibility Criteria

• Age: Up to 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.
• Are known to abuse drugs or alcohol.

Sponsors & Collaborators

• atHeart Medical: lead

Study Sites (32)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Los Robles Regional Medical Center

Thousand Oaks, California, 91360, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Joe DiMaggio Children's Hospital/Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Advocate Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48202, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43215, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Toronto General Hospital

Toronto, 6EN-249, Canada

Location

Hôpital cardiologique Haut-Leveque (CHU Bordeaux)

Bordeaux, 33604, France

Location

Service de Cardiologie Pédiatrique et Congénitale

Lille, 59000, France

Location

Hôpital Mere Enfants (CHU Nantes)

Nantes, 44093, France

Location

Hôpital Necker Enfants Malades

Paris, 75015, France

Location

Hôpital des Enfants (CHU Toulouse)

Toulouse, 31059, France

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, 1011, Switzerland

Location

University Children's Hospital Zurich

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Heart Septal Defects; Heart Septal Defects, Atrial; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Thomas Forbes, MD

  Joe DiMaggio Children&#39;s Hospital/Memorial Healthcare

  PRINCIPAL INVESTIGATOR

• Saibal Kar, MD

  Los Robles Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 19, 2020
• Study Start: March 12, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2032
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5); CH (2); US (24); CA (1)