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

• Sponsor: atHeart Medical (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04591392
• Collaborator: (none)
• Enrollment: 250
• Locations: 20
• Arm: 1
• Anticipated Duration (Months): 77.7
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heart Septal Defect; Heart Septal Defects, Atrial; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities	Device: reSept ASD Occluder	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Safety and Efficacy of the reSept ASD Occluder to Treat Patients With Clinically Significant Secundum Atrial Septal Defect
• Actual Study Start Date: Mar 12, 2021
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Subjects with 12-Month Composite Clinical Success [12 months]

   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.

2. Number of Subjects with CEC adjudicated Device- or Procedure-related SAEs [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)

Secondary Outcome Measures

1. ASD Closure Success among Technical Success Subjects [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.

2. Number of Subjects with Device- or Procedure-related AEs [12 months]

   Incidence of subjects experiencing one or more non serious device- or procedure-related adverse events through the 12-month follow up visit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 84 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 4 to 19 mm on screening diagnostic echocardiogram.

6. Isolated secundum ASD of size 4 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/defect margins to support the device. The rim is considered adequate unless it measures less than 5mm over an entire 45 degree segment.

9. 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Los Angeles	Los Angeles	California	United States	90027
2	Los Robles Regional Medical Center	Thousand Oaks	California	United States	91360
3	Yale University	New Haven	Connecticut	United States	06510
4	Joe DiMaggio Children's Hospital/Memorial Healthcare System	Hollywood	Florida	United States	33021
5	Advocate Children's Hospital	Oak Lawn	Illinois	United States	60453
6	Boston Children's Hospital	Boston	Massachusetts	United States	02115
7	University of Michigan	Ann Arbor	Michigan	United States	48109
8	Children's Hospital of Michigan	Detroit	Michigan	United States	48202
9	Mount Sinai Medical Center	New York	New York	United States	10029
10	Columbia University Medical Center/NYPH	New York	New York	United States	10032
11	Cincinnati Children's Hospital	Cincinnati	Ohio	United States	45229
12	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
13	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15224
14	Medical University of South Carolina	Charleston	South Carolina	United States	29425
15	Medical City Dallas Hospital	Dallas	Texas	United States	75230
16	Primary Children's Hospital	Salt Lake City	Utah	United States	84113
17	University of Virginia	Charlottesville	Virginia	United States	22908
18	Seattle Children's Hospital	Seattle	Washington	United States	98105
19	Hôpital cardiologique Haut-Leveque (CHU Bordeaux)	Bordeaux		France	33604
20	Hôpital des Enfants (CHU Toulouse)	Toulouse		France	31059

Sponsors and Collaborators

• atHeart Medical

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: atHeart Medical
• ClinicalTrials.gov Identifier: NCT04591392
• Other Study ID Numbers: 008-022
• First Posted: Oct 19, 2020
• Last Update Posted: May 2, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Diseases; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Congenital Abnormalities

Study Results

No Results Posted as of May 2, 2022