Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD (ASCENT ASD)
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|ClinicalTrials.gov Identifier: NCT04591392|
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : May 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Heart Septal Defect Heart Septal Defects, Atrial Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities||Device: reSept ASD Occluder||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Safety and Efficacy of the reSept ASD Occluder to Treat Patients With Clinically Significant Secundum Atrial Septal Defect|
|Actual Study Start Date :||March 12, 2021|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2027|
ASD closure with the reSept ASD Occluder
Device: reSept ASD Occluder
Transcatheter closure of secundum ASD using a permanent implant
- Number of Subjects with 12-Month Composite Clinical Success [ Time Frame: 12 months ]
- Clinically effective ASD closure, defined as no residual ASD or clinically insignificant residual ASD as determined by core laboratory review; and
- No re-intervention to treat the defect; and
- No device or procedure related serious adverse event.
- Number of Subjects with CEC adjudicated Device- or Procedure-related SAEs [ Time Frame: 12 months ]Incidence of subjects experiencing one or more serious device- or procedure related adverse events through the 12 month follow up visit, as adjudicated by the Clinical Events Committee (CEC)
- ASD Closure Success among Technical Success Subjects [ Time Frame: 1 month, 6 months and 12 months ]Assessment of device performance will include closure success, among subjects that were technical successes (i.e. successful placement and release of the reSept ASD Occluder at the ASD), defined as no residual ASD or clinically insignificant residual ASD determined by echocardiography. Assessment of closure success at each follow up through the 12-month follow up will be assessed by TTE.
- Number of Subjects with Device- or Procedure-related AEs [ Time Frame: 12 months ]Incidence of subjects experiencing one or more non serious device- or procedure-related adverse events through the 12-month follow up visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04591392
|Contact: Brandi Sadowski||+1 firstname.lastname@example.org|
|Principal Investigator:||Larry Latson, MD||Joe DiMaggio Children's Hospital/Memorial Healthcare|
|Principal Investigator:||Saibal Kar, MD||Los Robles Regional Medical Center|