What is the mechanism of action of this treatment?

The most common treatments for congenital heart defects (CHD) involving physical occlusion devices, such as the reSept ASD Occluder, work by physically closing the defect in the heart's septum. These devices are inserted via catheterization and deployed to cover the hole, thereby preventing abnormal blood flow between the heart chambers. This is crucial for CHD patients as it helps restore normal hemodynamics, reduces the risk of complications like heart failure and arrhythmias, and improves overall cardiac function. By addressing the structural defect directly, these treatments offer a minimally invasive solution with quicker recovery times compared to traditional surgical methods.

What side effects are associated with this type of intervention?

Common side effects of device-based treatments for congenital heart defects, such as the reSept ASD Occluder, include device migration, residual shunts, arrhythmias, thrombus formation, and infection. Procedural risks may involve bleeding, vascular complications, and adverse reactions to anesthesia. Long-term complications can include device erosion into adjacent cardiac structures and the need for re-intervention.

What prior FDA approvals exist?

The FDA has approved several devices for the treatment of congenital heart defects, particularly for secundum atrial septal defects (ASD). One notable device is the Amplatzer Septal Occluder, which is designed to close the hole in the heart's septum. This device, like the reSept ASD Occluder, physically occludes the defect to prevent abnormal blood flow between the heart's chambers. Other similar devices include the Gore Helex Septal Occluder and the CardioSEAL Septal Occlusion System. These devices have been shown to be effective in treating ASDs by providing a minimally invasive alternative to open-heart surgery.

What other types of research exist?

Promising novel alternatives to the reSept ASD Occluder for treating atrial septal defects in congenital heart defects patients include: 1) Gore Cardioform Septal Occluder, which offers a flexible and conformable design for ASD closure; 2) Amplatzer Septal Occluder, known for its high success rate and ease of deployment; and 3) Occlutech Figulla Flex II, which provides a minimally invasive option with a self-centering mechanism. These devices have demonstrated efficacy and safety in clinical settings and are viable options for patients considering treatment in 2024.

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ASD Occluder

reSept ASD Occluder for Atrial Septal Defect (ASCENT ASD Trial)

N/A

Recruiting

Led By Saibal Kar, MD

Research Sponsored by atHeart Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Body weight ≥ 15 kg / 33 lb

Must not have

Patients with the diagnosis of Patent Foramen Ovale (PFO)

Subjects having undergone left sided structural heart interventions performed via transseptal access (e.g. Mitraclip, LAAO, percutaneous mitral valve replacement)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month, 6 months and 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include discomfort or complications from the device implantation procedure such as bleeding or infection, allergic reactions to materials in the occluder or medications used during the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take Aspirin and Heparin as required around my procedure.

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I weigh at least 33 pounds.

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I can take Aspirin and Heparin as required for the study.

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My heart has enough space for the implant without affecting nearby critical parts.

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I am younger than 85 years old.

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My heart has enough space for the implant without affecting nearby critical parts.

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I am younger than 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a hole in my heart (PFO).

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I have had a heart procedure done through a small hole in my heart.

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I do not have allergies to the trial's drugs or a history of bleeding, clotting disorders, or untreated ulcers.

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I do not have significant heart problems that could affect the study.

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I have a history of heart rhythm problems that needed treatment.

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I have an active heart infection or another infection in my blood.

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I do not have severe heart valve issues or high blood pressure in the lungs that would prevent ASD closure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month, 6 months and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month, 6 months and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Subjects with 12-Month Composite Clinical Success

Number of Subjects with CEC adjudicated Device- or Procedure-related SAEs

Secondary study objectives

ASD Closure Success among Technical Success Subjects

Number of Subjects with Device- or Procedure-related AEs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DeviceExperimental Treatment1 Intervention

ASD closure with the reSept ASD Occluder

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for congenital heart defects (CHD) involving physical occlusion devices, such as the reSept ASD Occluder, work by physically closing the defect in the heart's septum. These devices are inserted via catheterization and deployed to cover the hole, thereby preventing abnormal blood flow between the heart chambers. This is crucial for CHD patients as it helps restore normal hemodynamics, reduces the risk of complications like heart failure and arrhythmias, and improves overall cardiac function. By addressing the structural defect directly, these treatments offer a minimally invasive solution with quicker recovery times compared to traditional surgical methods.

Transcatheter Intervention for Congenital Defects Involving the Great Vessels: JACC Review Topic of the Week.