reSept ASD Occluder for Atrial Septal Defect

(ASCENT ASD Trial)

Recruiting at 26 trial locations

Overseen By Bryan Goldstein, MD

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. ^{1 2 3 4 5}

What 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. ^{1 2 3 4 6}

Research Team

Saibal Kar, MD

Principal Investigator

Los Robles Regional Medical Center

Larry Latson, MD

Principal Investigator

Joe DiMaggio Children's Hospital/Memorial Healthcare

Eligibility 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.

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.

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

Treatment Details

Interventions

• reSept ASD Occluder (ASD Occluder)

Trial Overview 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.

Participant Groups

Group I: Device Experimental Treatment 1 Intervention

ASD closure with the reSept ASD Occluder

reSept ASD Occluder is already approved in Canada, Switzerland for the following indications:

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

Who Is Running the Clinical Trial?

atHeart Medical

Lead Sponsor

Trials

2

Recruited

260+

Findings from Research

The Carag Bioresorbable Septal Occluder™ (CBSO) was successfully used in four children with atrial septal defects (ASD), demonstrating 100% effective closure and procedural safety during the first 12 months of follow-up.

The CBSO device, made from a bioresorbable material, showed no complications or inflammatory reactions, and the interatrial septum thickness remained stable, suggesting it could be a promising alternative to traditional metal devices for ASD closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Closure of Atrial Septal Defect with Carag Bioresorbable Septal Occluder™: First-in-Child Experience with 12-MonthFollow-Up. Callegari, A., Quandt, D., Nordmeyer, J., et al.[2023]

The BioSTAR occluder, made from a bioresorbable collagen matrix, demonstrated effective closure of atrial septal defects (ASDs) in a study involving 36 young sheep, with complete replacement by host tissue after 2 years.

Compared to traditional occluders, the BioSTAR device showed improved biocompatibility and reduced thrombogencity due to its heparin coating, suggesting a safer option for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventional atrial septal defect closure using a totally bioresorbable occluder matrix: development and preclinical evaluation of the BioSTAR device. Jux, C., Bertram, H., Wohlsein, P., et al.[2019]

The ASD Occlusion System (ASDOS) was successfully implanted in all 20 patients with atrial-septal defects, demonstrating high procedural safety with no major complications during a follow-up of approximately 14 months.

The ASDOS system allows for individual adaptation to the defect's anatomy, which enhances closure effectiveness, although 40% of patients had a small residual shunt detected by echocardiography after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter closure of atrial-septal defects and patent foramen ovale in adults: optimal anatomic adaptation of occlusion device. Hoepp, HW., Deutsch, HJ., La Rosée, K., et al.[2019]

The AbsnowTM device, a biodegradable occluder for closing atrial septal defects (ASD), showed 100% technical and procedural success in a small study of 5 pediatric patients over a 3-year follow-up, indicating its safety with no serious adverse events.

However, by the 3-year mark, 3 out of 5 patients developed new residual shunts, which increased in size over time, suggesting that while the device is safe, its long-term efficacy may be compromised and requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Clinical Experience with the Biodegradable AbsnowTM Device for Percutaneous Closure of Atrial Septal Defect: A 3-Year Follow-Up. Li, Y., Xie, Y., Li, B., et al.[2022]

The GORE(®) Septal Occluder was successfully used to close atrial septal defects (ASDs) in 22 patients, with no complications reported during the procedure and follow-up, indicating its safety and efficacy.

All patients experienced resolution or improvement in symptoms after the procedure, and there were no residual shunts or new onset arrhythmias, demonstrating the device's effectiveness in treating ASDs of various anatomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First experiences with the GORE(®) Septal Occluder in children and adults with atrial septal defects. Nyboe, C., Hjortdal, VE., Nielsen-Kudsk, JE.[2016]

The study demonstrates the healing process after using the Nit-Occlud ASD-R occluder for closing atrial septal defects in a sheep model, indicating its potential effectiveness in clinical applications.

Histological analysis confirmed the formation of neotissue over the device, suggesting that the occluder promotes tissue integration and healing, which is crucial for long-term success in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nit-Occlud atrial septal defect occluder device: Histological characterisation of the healing process. Perdreau, E., Jalal, Z., Sigler, M.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transcatheter Closure of Atrial Septal Defect with Carag Bioresorbable Septal Occluder™: First-in-Child Experience with 12-MonthFollow-Up. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Interventional atrial septal defect closure using a totally bioresorbable occluder matrix: development and preclinical evaluation of the BioSTAR device. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Transcatheter closure of atrial-septal defects and patent foramen ovale in adults: optimal anatomic adaptation of occlusion device. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Initial Clinical Experience with the Biodegradable AbsnowTM Device for Percutaneous Closure of Atrial Septal Defect: A 3-Year Follow-Up. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

First experiences with the GORE(®) Septal Occluder in children and adults with atrial septal defects. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Nit-Occlud atrial septal defect occluder device: Histological characterisation of the healing process. [2021]