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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04591392
Other study ID # 008-022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 12, 2021
Est. completion date December 2030

Study information

Verified date December 2023
Source atHeart Medical
Contact Brandi Sadowski
Phone +1 408-412-7245
Email b.sadowski@atheartmedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date December 2030
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group N/A to 84 Years
Eligibility 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 Design


Intervention

Device:
reSept ASD Occluder
Transcatheter closure of secundum ASD using a permanent implant

Locations

Country Name City State
France Hôpital cardiologique Haut-Leveque (CHU Bordeaux) Bordeaux
France Hôpital Mere Enfants (CHU Nantes) Nantes
France Hôpital Necker Enfants Malades Paris
France Hôpital des Enfants (CHU Toulouse) Toulouse
United States University of Michigan Ann Arbor Michigan
United States Children's Healthcare of Atlanta Atlanta Georgia
United States Children's Hospital Colorado Aurora Colorado
United States Boston Children's Hospital Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States University of Virginia Charlottesville Virginia
United States Cincinnati Children's Hospital Cincinnati Ohio
United States Nationwide Children's Hospital Columbus Ohio
United States Medical City Dallas Hospital Dallas Texas
United States Children's Hospital of Michigan Detroit Michigan
United States Joe DiMaggio Children's Hospital/Memorial Healthcare System Hollywood Florida
United States Texas Children's Hospital Houston Texas
United States Riley Hospital for Children Indianapolis Indiana
United States Children's Hospital of Los Angeles Los Angeles California
United States Yale University New Haven Connecticut
United States Columbia University Medical Center/NYPH New York New York
United States Mount Sinai Medical Center New York New York
United States Advocate Children's Hospital Oak Lawn Illinois
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
United States Washington University School of Medicine Saint Louis Missouri
United States Primary Children's Hospital Salt Lake City Utah
United States Seattle Children's Hospital Seattle Washington
United States Los Robles Regional Medical Center Thousand Oaks California

Sponsors (1)

Lead Sponsor Collaborator
atHeart Medical

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects with 12-Month Composite Clinical Success Clinically effective ASD closure, defined as no residual ASD or clinically insignificant residual ASD as determined by core laboratory review; and
No re-intervention to treat the defect; and
No device or procedure related serious adverse event.
12 months
Primary 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 ASD Closure Success among Technical Success Subjects 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
Secondary Number of Subjects with Device- or Procedure-related AEs Incidence of subjects experiencing one or more non serious device- or procedure-related adverse events through the 12-month follow up visit. 12 months
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