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

Cardiovascular Diseases Clinical Trial

— ASCENT ASD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04591392
• Other study ID #: 008-022
• Status: Recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

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

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