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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 6 months and 12 months
Awards & highlights
ASCENT ASD Trial Summary
This trial is testing a new device to treat patients with a heart condition called atrial septal defect. The device will be used to close the hole in the heart and the trial will evaluate the safety and efficacy of the device.
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.Check my eligibility
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.See study design
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.
ASCENT ASD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I am younger than 85 years old.
ASCENT ASD Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Subjects with 12-Month Composite Clinical Success
Number of Subjects with CEC adjudicated Device- or Procedure-related SAEs
Secondary outcome measures
ASD Closure Success among Technical Success Subjects
Number of Subjects with Device- or Procedure-related AEs
ASCENT ASD Trial Design
1Treatment groups
Experimental Treatment
Group I: DeviceExperimental Treatment1 Intervention
ASD closure with the reSept ASD Occluder
Find a Location
Who is running the clinical trial?
atHeart MedicalLead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
Saibal Kar, MDPrincipal InvestigatorLos Robles Regional Medical Center
5 Previous Clinical Trials
5,458 Total Patients Enrolled
Larry Latson, MDPrincipal InvestigatorJoe DiMaggio Children's Hospital/Memorial Healthcare
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a hole in my heart (PFO).I can take Aspirin and Heparin as required around my procedure.I have had a heart procedure done through a small hole in my heart.I weigh at least 33 pounds.I am either male or female.I am either male or female.Your heart needs to have a strong enough wall to support the medical device. If the wall measures less than 5mm in more than two views, it may not be strong enough.I can take Aspirin and Heparin as required for the study.I do not have allergies to the trial's drugs or a history of bleeding, clotting disorders, or untreated ulcers.I have a heart condition that needs treatment according to my doctor.My heart has enough space for the implant without affecting nearby critical parts.I do not have significant heart problems that could affect the study.I can give my consent or, if I'm a minor, my parent or guardian can.I am younger than 85 years old.I have a heart condition that needs treatment according to my doctor.My heart has enough space for the implant without affecting nearby critical parts.I have a history of heart rhythm problems that needed treatment.I have an active heart infection or another infection in my blood.I can make my own medical decisions or have a guardian who can.I have not had any untreated infections in the last 30 days.I do not have severe heart valve issues or high blood pressure in the lungs that would prevent ASD closure.I am younger than 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Congenital Heart Defects Patient Testimony for trial: Trial Name: NCT04591392 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are included in the research project?
"That is correct, the online information from clinicaltrials.gov affirms that this particular trial is actively looking for participants. The first posting was on March 12th 2021 with the most recent update being November 7th 2022. They are hoping to recruit 250 patients in total from 17 different locations."
Answered by AI
Are we currently enrolling participants for this research?
"The trial is still recruiting patients, as of the most recent update on clinicaltrials.gov from November 7th, 2022. The study was first posted March 12th, 2021."
Answered by AI
At how many distinct hospitals or research centers is this investigation being conducted?
"There are a total of 17 clinical trial sites for this study. While some are based in large cities such as Philadelphia, New york and Cincinnati, others are more spread out. If you enroll in the trial, try to pick a location that is close to minimize travel requirements."
Answered by AI
Who else is applying?
What site did they apply to?
Mount Sinai Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am looking for bioabsorbable occluder, as current ones stays in heart permanently and may cause issues later.
PatientReceived 1 prior treatment
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