ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study

Stopped early

Conditions studied: Atrial Septal Defect Secundum

In brief

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.)

Key facts

Study ID

NCT02353351

Run by

Abbott Medical Devices

People needed

602

Starts

2015-01-19

Expected to finish

2017-02-24

Last updated by the study team

2019-02-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To participate in this clinical investigation, the patient must meet all of the following 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.)

You may not qualify if…

• Patient is not eligible for clinical investigation participation if he/she meets any of the following 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

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of Arkansas — Little Rock, Arkansas, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• University of Southern California — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Huntington Memorial Hospital — Pasadena, California, United States
• Rady Children's Hospital — San Diego, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Nemours/Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
• Baptist Medical Center — Jacksonville, Florida, United States
• Florida Hospital Orlando — Orlando, Florida, United States
• Arnold Palmer Hospital for Children — Orlando, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Iowa Heart Center / Mercy Medical Center — West Des Moines, Iowa, United States
• Children's Hospital — New Orleans, Louisiana, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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