Active — Not RecruitingNot Applicable

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

United States250 participantsStarted 2021-03-12

Plain-language summary

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

Age range84 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 5 to 19 mm on screening diagnostic echocardiogram.
✓. Isolated secundum ASD of size 8 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 to support the device. The rim is considered inadequate if it measures less than 5mm in more than two views of a critical structure

✕. 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.
✕. Active endocarditis or other infection(s) producing bacteremia.
✕. History of atrial tachycardia, atrial fibrillation or flutter, AV block, or ventricular arrhythmia requiring antiarrhythmic medication, pacemaker or AICD.

Number of Subjects with 12-Month Composite Clinical Success

Timeframe: 12 months

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

Timeframe: 12 months

NCT IDNCT04591392

SponsoratHeart Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Who can participate

Age range84 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 5 to 19 mm on screening diagnostic echocardiogram.
✓. Isolated secundum ASD of size 8 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 to support the device. The rim is considered inadequate if it measures less than 5mm in more than two views of a critical structure

✕. 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.
✕. Active endocarditis or other infection(s) producing bacteremia.
✕. History of atrial tachycardia, atrial fibrillation or flutter, AV block, or ventricular arrhythmia requiring antiarrhythmic medication, pacemaker or AICD.