Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cardiovascular Abnormalities
- Cardiovascular Diseases
- Congenital Abnormalities
- Heart Defects, Congenital
- Heart Diseases
- Heart Septal Defect
- Heart Septal Defects, Atrial
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 84 years
- Gender
- Both males and females
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 approve...
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.
Tracking Information
- NCT #
- NCT04591392
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Larry Latson, MD Joe DiMaggio Children's Hospital/Memorial Healthcare Principal Investigator: Saibal Kar, MD Los Robles Regional Medical Center
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