reSept ASD Occluder for Atrial Septal Defect

(ASCENT ASD Trial)

Not currently recruiting at 32 trial locations

Overseen By Bryan Goldstein, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: atHeart Medical

Must be taking: Aspirin, Heparin

Disqualifiers: Pregnancy, Valve dysfunction, Cardiovascular abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to evaluate the safety and effectiveness of a new device called the reSept ASD Occluder, designed to treat atrial septal defect (ASD). ASD is a heart condition characterized by a hole in the wall between the heart's upper chambers, causing blood flow issues. Individuals with a significant ASD and symptoms such as heart overload might be suitable candidates. Participants should be able to take medications like aspirin and should not have other major heart problems. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance future ASD treatments.

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 prior data suggests that the reSept ASD Occluder is safe for treating atrial septal defect?

Research shows that the reSept ASD Occluder is safe to use. Studies have reported that it successfully closes the hole in the heart (atrial septal defect) in all cases. The device features a special frame that gradually dissolves, leaving no metal behind, which can lower long-term risks.

Data from three groups of patients showed positive safety results. Additionally, testing over ten years has proven the device to be both effective and safe in the long run. These findings suggest that patients tolerate the reSept ASD Occluder well, with no major side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The reSept ASD Occluder is unique because it offers a novel approach to closing atrial septal defects (ASDs) with a potentially less invasive device. Unlike traditional options like surgical repair or other occlusion devices, the reSept Occluder is designed to simplify the procedure, potentially reducing recovery time and improving patient comfort. Researchers are excited about this treatment because it could offer a safer and more efficient way to treat ASDs, making it a promising option for patients who need a less invasive solution.

What evidence suggests that the reSept ASD Occluder is effective for atrial septal defect?

Research has shown that the reSept ASD Occluder, which participants in this trial will receive, effectively closes holes in the heart, known as atrial septal defects (ASD), with a 100% success rate. This device is unique because the body can absorb it over time, leaving no metal behind. Long-term studies over 10 years have confirmed its safety and effectiveness. Additionally, comparisons with other FDA-approved devices indicate that it meets the required performance standards. Overall, the evidence strongly supports its potential to effectively treat atrial septal defects. ^{1 2 3 4 6}

Who Is on the Research Team?

Saibal Kar, MD

Principal Investigator

Los Robles Regional Medical Center

Thomas Forbes, MD

Principal Investigator

Joe DiMaggio Children's Hospital/Memorial Healthcare

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• reSept 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.

How Is the Trial Designed?

Group I: Device Experimental Treatment 1 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

Who Is Running the Clinical Trial?

atHeart Medical

Lead Sponsor

Trials

2

Recruited

260+

Published Research Related to This Trial

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 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 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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9822760/

Transcatheter Closure of Atrial Septal Defect with Carag ... Effective defect closure with the device was 100%. Echocardiographic measurements of the thickness of the interatrial septum did not show any relevant increase ...

2. citoday.com citoday.com/news/atheart-medicals-resept-asd-occluder-evaluated-in-fih-and-pivotal-studies

atHeart Medical's reSept ASD Occluder Evaluated in FIH ... 10-year outcomes from the first-in-human (FIH) trial showing long-term efficacy and safety of the device were presented by Kolja Sievert, MD, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04591392

Safety and Efficacy Study of reSept ASD Occluder for ... Outcomes/endpoints of the clinical investigation will be compared with established performance goals for FDA approved transcatheter secundum ASD occluders.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9831926/

Atrial Septal Defect Closure With the ReAces Device The newest biodegradable device (Carag Septal Occluder, CARAG) has shown promising results in a small proof-of-concept study. However, its ...

5. dicardiology.com dicardiology.com/content/promising-long-and-short-term-clinical-data-show-potential-first-asd-occluder-bioresorbable

and Short-term Clinical Data Show Potential of First ASD ... reSept is the first ASD occluder with a bioresorbable, metal-free frame, designed to enable future transseptal treatment.

6. massdevice.com massdevice.com/atheart-positive-data-asd-occluder-bioresorbable/

AtHeart reports positive data for bioresorbable ASD occluder Data from three patient cohorts showed positive efficacy and safety outcomes for the occluder, which features a bioresorbable, metal-free frame.