Clinical trial NCT04591392: Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD
Official title: Evaluation of the Safety and Efficacy of the reSept ASD Occluder to Treat Patients With Clinically Significant Secundum Atrial Septal Defect
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Septal Defect
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Lead sponsor: atHeart Medical
Sponsor class: INDUSTRY
First posted: 2020-10-19
Enrollment: 250
Sex: ALL
Maximum age (years): 84
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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).

Primary outcomes:
measure: Number of Subjects with 12-Month Composite Clinical Success
timeFrame: 12 months
measure: Number of Subjects with CEC adjudicated Device- or Procedure-related SAEs
timeFrame: 12 months
Secondary outcomes:
measure: ASD Closure Success among Technical Success Subjects
timeFrame: 1 month, 6 months and 12 months
measure: Number of Subjects with Device- or Procedure-related AEs
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Hollywood
country: United States
facility: Joe DiMaggio Children's Hospital/Memorial Healthcare System
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Oak Lawn
country: United States
facility: Advocate Children's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Toronto
country: Canada
facility: Toronto General Hospital
city: Bordeaux
country: France
facility: Hôpital cardiologique Haut-Leveque (CHU Bordeaux)
city: Lille
country: France
facility: Service de Cardiologie Pédiatrique et Congénitale
city: Nantes
country: France
facility: Hôpital Mere Enfants (CHU Nantes)
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
city: Toulouse
country: France
facility: Hôpital des Enfants (CHU Toulouse)
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: Joe DiMaggio Children&#39;s Hospital/Memorial Healthcare
name: Thomas Forbes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Los Robles Regional Medical Center
name: Saibal Kar, MD
role: PRINCIPAL_INVESTIGATOR
References: