Heart Septal DefectASCENT ASDNCT04591392
Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD
A study testing reSept ASD Occluder in people with Heart Septal Defect and Heart Septal Defects, Atrial, run by atHeart Medical at 32 sites in 4 countries.
Trial summary
Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect Read more about this study
- Who is it for?
- Ages Up to 84 years
- Conditions the study is for
- Heart Septal Defect, Heart Septal Defects, Atrial, Heart Defects, Congenital
- What is being tested?
- reSept ASD Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 32 sitesin 4 countries
- Study dates
- 12 Mar 2021to Mar 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 84 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- Are known to abuse drugs or alcohol.
- Patients with the diagnosis of Patent Foramen Ovale (PFO).
Trial locations and contacts
32 sites in 4 countries.
32 sites in 4 countries
United States24 sites
University of Michigan
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Boston Children's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22908
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43215
Medical City Dallas Hospital
Dallas, Texas, 75230
Children's Hospital of Michigan
Detroit, Michigan, 48202
Joe DiMaggio Children's Hospital/Memorial Healthcare System
Hollywood, Florida, 33021
Texas Children's Hospital
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Yale University
New Haven, Connecticut, 06510
Mount Sinai Medical Center
New York, New York, 10029
Advocate Children's Hospital
Oak Lawn, Illinois, 60453
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Primary Children's Hospital
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
Washington University School of Medicine
St Louis, Missouri, 63110
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
France5 sites
Hôpital cardiologique Haut-Leveque (CHU Bordeaux)
Bordeaux, 33604
Service de Cardiologie Pédiatrique et Congénitale
Lille, 59000
Hôpital Mere Enfants (CHU Nantes)
Nantes, 44093
Hôpital Necker Enfants Malades
Paris, 75015
Hôpital des Enfants (CHU Toulouse)
Toulouse, 31059
Switzerland2 sites
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011
University Children's Hospital Zurich
Zurich, 8032
About this study
Official title: Evaluation of the Safety and Efficacy of the reSept ASD Occluder to Treat Patients With Clinically Significant Secundum Atrial Septal Defect
Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect
Read the 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.
- Conditions
- Heart Septal Defect, Heart Septal Defects, Atrial, Heart Defects, Congenital, Cardiovascular Abnormalities, Cardiovascular Diseases, Heart Diseases
- Being tested
- reSept ASD Occluder
- Medical subject headings
- Heart Septal Defects, Heart Septal Defects, Atrial, Heart Defects, Congenital, Cardiovascular Abnormalities, Cardiovascular Diseases, Heart Diseases, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reSept ASD OccluderDevice
Transcatheter closure of secundum ASD using a permanent implant
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | ASD closure with the reSept ASD Occluder Receives: Device: reSept ASD Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 1 month, 6 months and 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start12 Mar 2021
- Primary completionMar 2027 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Septal DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- atHeart Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Forbes, MD, Principal investigator, Joe DiMaggio Children's Hospital/Memorial HealthcareSaibal Kar, MD, Principal investigator, Los Robles Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591392
- Sponsor's protocol ID
- 008-022
- Acronym
- ASCENT ASD
- Status last verified
- May 2025
- First submitted
- 6 Oct 2020
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the reSept ASD Occluder to Treat Patients With Clinically Significant Secundum Atrial Septal Defect
- ClinicalTrials.gov ID
- NCT04591392
- Acronym / sponsor ID
- ASCENT ASD / 008-022
- Conditions
- Heart Septal Defect, Heart Septal Defects, Atrial, Heart Defects, Congenital, Cardiovascular Abnormalities, Cardiovascular Diseases, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- atHeart MedicalIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: reSept ASD OccluderASD closure with the reSept ASD Occluder |
Who may qualify
- Ages
- Up to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reSept ASD OccluderTranscatheter closure of secundum ASD using a permanent implant | Device | Device |
Primary outcome
Number of Subjects with 12-Month Composite Clinical Success
Time frame: 12 months
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.
Number of Subjects with CEC adjudicated Device- or Procedure-related SAEs
Time frame: 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)
2 secondary outcomes
ASD Closure Success among Technical Success Subjects
Time frame: 1 month, 6 months and 12 months
Number of Subjects with Device- or Procedure-related AEs
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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Atrial Septal Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Forbes, MD principal investigator
Joe DiMaggio Children's Hospital/Memorial Healthcare
Saibal Kar, MD principal investigator
Los Robles Regional Medical Center
32 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reSept ASD Occluder in people with Heart Septal Defect and Heart Septal Defects, Atrial, run by atHeart Medical at 32 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, France, Switzerland, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects with 12-Month Composite Clinical Success (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.