Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD

  • STATUS
    Recruiting
  • End date
    Sep 3, 2027
  • participants needed
    250
  • sponsor
    atHeart Medical
Updated on 3 December 2021
aspirin

Summary

Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect

Description

Prospective, three-stage, single arm, multi-site, clinical investigation evaluating the safety and efficacy of the reSept ASD Occluder in treating clinically significant secundum ASD. Outcomes/endpoints of the clinical investigation will be compared with established performance goals for FDA approved transcatheter secundum ASD occluders.

Details
Condition Heart disease, Congenital Heart Defect, Atrial septal defect, Heart Septal Defects, Cardiovascular Disease, Cardiovascular Abnormalities, CONGENITAL ANOMALY NOS, Congenital Heart Disease, Growth Hormone Deficiencies/Abnormalities, Female Hormonal Deficiencies/Abnormalities, Male Hormonal Deficiencies/Abnormalities, Heart Defect, Birth Defects, Cardiac Disease, cardiac diseases, heart diseases, cardiac disorders, cardiac disorder, heart disorder, septal defect, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders
Treatment reSept ASD Occluder
Clinical Study IdentifierNCT04591392
SponsoratHeart Medical
Last Modified on3 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All responses must be Yes to be eligible
Age < 85 years
Body weight 15 kg / 33 lb
Males and Females
Clinically significant, isolated secundum ASD associated with a L-R shunt and signs of RV volume overload that, based upon the expertise of attending physicians requires treatment
ASD of size 4 to 19 mm on screening diagnostic echocardiogram
Isolated secundum ASD of size 4 to 22 mm on stop flow balloon diameter, based upon echocardiographic and fluoroscopic evidence obtained at procedure
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
Adequate septal rim/defect margins to support the device. The rim is considered adequate unless it measures less than 5mm over an entire 45 degree segment
Capable of giving informed consent, or, for minors, consent of the parent or legal guardian, and willing to comply with the clinical investigation requirements

Exclusion Criteria

All responses must be No to be eligible
Pregnancy. Females with child-bearing potential are required to be tested for pregnancy prior to treatment, in accordance with the local institution's policy. For minor females, a pregnancy test will be done in accordance with the local institution's policy
Any significant valve dysfunction that contraindicates ASD closure, or increased pulmonary vascular resistance/severe pulmonary hypertension
Acquired pathological or congenital abnormalities of the cardiovascular system (other than isolated secundum ASD; e.g. congenital malformations, calcification, myocardial infarction, intracardiac thrombi, dilated cardiomyopathy, untreated coronary disease or CAD treated with a stent in the prior 12 months) being clinically significant, that would interfere with the conduct of the clinical investigation
Subjects having undergone left sided structural heart interventions performed via transseptal access (e.g. Mitraclip, LAAO, percutaneous mitral valve replacement)
Evidence of thrombus in the left atrium, left atrial appendage, other cardiac chamber, or the inferior vena cava
Sepsis or any other infection that was not successfully treated at least 30 days prior to device placement
History of atrial tachycardia, atrial fibrillation or flutter, AV block, or ventricular arrhythmia requiring antiarrhythmic medication, pacemaker or AICD
Active endocarditis or other infection(s) producing bacteremia
Vasculature is of inadequate size to accommodate all procedural instrumentation
Known allergy to investigational device components or medications, or other contraindication to clinical investigation medications (acetylsalicylic acid, heparin), including a documented history of bleeding, clotting or coagulation disorders, untreated ulcer or any other contraindications to acetylsalicylic acid or antiplatelet therapy
Known hypercoagulable state
Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation as well as any severe concurrent illness that would limit life expectancy (e.g. malignancies)
Currently an active subject in an investigational drug or device study that could confound the results of this study
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
Are known to abuse drugs or alcohol
Patients with the diagnosis of Patent Foramen Ovale (PFO)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note