TerminatedNot Applicable

ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study

Stopped: The sponsor's study closure justification addressed the 522 Order's questions.

United States602 participantsStarted 2015-01-19

Plain-language summary

Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)

Who can participate

SexALL

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

Inclusion criteria

✓. Patient indicated for ASD closure who has echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement) and is implanted with the ASO device Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure
✓. Patient is willing and able to complete the follow-up requirements of this study
✓. Patient signs the informed consent (or a legal representative signs the informed consent.)

Exclusion criteria

✕. Patient is known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery
✕. Patient is known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement
✕. Patient is known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy (unless another anti-platelet agent can be administered for 6 months)
✕. Patient is known to have a demonstrated intracardiac thrombus on echocardiography
✕. Patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization
✕. Patient has margins of defect that are less than 5 mm to the coronary sinus, AV valves or right upper lobe pulmonary vein

What they're measuring

Cumulative incidence of cardiac erosion

Timeframe: 1 year

Trial details

NCT IDNCT02353351

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-02-24

View on ClinicalTrials.gov More Atrial Septal Defect Secundum trials