reSept ASD Occluder for Atrial Septal Defect
(ASCENT ASD Trial)
Recruiting in Palo Alto (17 mi)
+26 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: atHeart Medical
Must be taking: Aspirin, Heparin
Disqualifiers: Pregnancy, Valve dysfunction, Cardiovascular abnormalities, others
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing the safety and effectiveness of the reSept ASD Occluder, a device that closes a specific type of heart hole. It targets patients with secundum atrial septal defect and works by sealing the hole like a patch.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but you must be able to take aspirin and heparin as required by the study. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the reSept ASD Occluder treatment for Atrial Septal Defect?
Research on the Carag Bioresorbable Septal Occluder, a similar device, showed that it effectively closed atrial septal defects in children with 100% success and no complications over a 12-month follow-up period.
12345What makes the reSept ASD Occluder treatment unique for atrial septal defect?
The reSept ASD Occluder is unique because it is a bioresorbable device, meaning it gradually dissolves in the body over 18-24 months, potentially reducing long-term complications associated with metal frameworks used in other devices.
12346Eligibility Criteria
This trial is for males and females under 85 years old, weighing at least 33 lbs, with a specific heart defect called secundum atrial septal defect (ASD) that's between 5 to 22 mm. Participants must be able to take aspirin and heparin, have an ASD that requires treatment due to right ventricle overload, and have enough tissue around the defect for device placement.Inclusion Criteria
I can take Aspirin and Heparin as required around my procedure.
Isolated secundum ASD of size 8 to 22 mm on stop flow balloon diameter, based upon echocardiographic and fluoroscopic evidence obtained at procedure.
I weigh at least 33 pounds.
+16 more
Exclusion Criteria
I have been diagnosed with a hole in my heart (PFO).
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
I have had a heart procedure done through a small hole in my heart.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
ASD closure with the reSept ASD Occluder
1 month
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Follow-up visits at 1 month, 6 months, and 12 months
Participant Groups
The reSept ASD Occluder is being tested in this study. It's a device designed to close the hole in the heart of patients with secundum ASD—a type of congenital heart defect—without needing open-heart surgery.
1Treatment groups
Experimental Treatment
Group I: DeviceExperimental Treatment1 Intervention
ASD closure with the reSept ASD Occluder
reSept ASD Occluder is already approved in United States, Canada, Switzerland for the following indications:
🇺🇸 Approved in United States as reSept ASD Occluder for:
- Clinically significant secundum atrial septal defect
🇨🇦 Approved in Canada as reSept ASD Occluder for:
- Clinically significant secundum atrial septal defect
🇨🇭 Approved in Switzerland as reSept ASD Occluder for:
- Clinically significant secundum atrial septal defect
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Hospital of Los AngelesLos Angeles, CA
Cincinnati Children's HospitalCincinnati, OH
Children's Hospital of MichiganDetroit, MI
Los Robles Regional Medical CenterThousand Oaks, CA
More Trial Locations
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Who Is Running the Clinical Trial?
atHeart MedicalLead Sponsor
References
Transcatheter Closure of Atrial Septal Defect with Carag Bioresorbable Septal Occluder™: First-in-Child Experience with 12-MonthFollow-Up. [2023]Label="Background" NlmCategory="UNASSIGNED">Nowadays, transcatheter device closure of an atrial septal defect (ASD) is a standard approach in children. Potential early and long-term side effects or complications related to the metal framework of the devices are a known issue. A bioresorbable device such as the Carag Bioresorbable Septal Occluder™ (CBSO) could resolve such complications. Material and Results. The Carag Bioresorbable Septal Occluder™ (CBSO; Carag AG, Baar, Switzerland) is a self-centering double disk, repositionable, and retractable device with a bioresorbable framework (polylactic-co-glycolic acid), which is almost completely resorbed by 18-24 months postimplantation. This manuscript reports the four first-in-child ASD device closures using a CBSO. The patients' age was median (IQ1-IQ3), 4.5 years (4-7.25). Weight was 21.3 kg (17.6-32.7). We demonstrated procedural feasibility and safety. Effective defect closure with the device was 100%. Echocardiographic measurements of the thickness of the interatrial septum did not show any relevant increase over a 12-monthfollow-up period. There were no residual defects found after the procedure or later during the resorption process. The patients showed no evidence of any local or systemic inflammatory reaction.
Interventional atrial septal defect closure using a totally bioresorbable occluder matrix: development and preclinical evaluation of the BioSTAR device. [2019]We sought to test the hypothesis that interventional atrial septal defect (ASD) closure can be performed safely and effectively using a bioresorbable occluder matrix.
Transcatheter closure of atrial-septal defects and patent foramen ovale in adults: optimal anatomic adaptation of occlusion device. [2019]For transcatheter closure of atrial-septal defects, different occlusion systems are available. The purpose of this study was to examine the clinical feasibility of the ASD Occlusion System (ASDOS, Dr Osypka GmbH, Grenzach-Wyhlen, Germany) and to evaluate the short- and long-term results.
Initial Clinical Experience with the Biodegradable AbsnowTM Device for Percutaneous Closure of Atrial Septal Defect: A 3-Year Follow-Up. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE">We reported the 3-year follow-up results of initial clinical experience with the AbsnowTM device, a novel biodegradable occluder for percutaneous closure of atrial septal defect (ASD).
First experiences with the GORE(®) Septal Occluder in children and adults with atrial septal defects. [2016]In this study, we report the first experiences with the GORE(®) Septal Occluder in transcatheter treatment of patients with atrial septal defects (ASD).
Nit-Occlud atrial septal defect occluder device: Histological characterisation of the healing process. [2021]We describe the healing process following transcatheter implantation of the Nit-Occlud ASD-R occluder (PFM medical, Cologne, Germany) for atrial septal defect closure in a sheep model with histological confirmation of neotissue formation covering the device.