AMPLATZER Duct Occluder II Additional Sizes (ADO II AS)

Abbott

Status: Completed

Conditions: Patent Ductus Arteriosus

Treatments: Device: ADO II AS (PDA closure)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03055858

SJM-CIP-10171

Details and patient eligibility

About

The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance.

To account for subject dropout, up to 50 subjects will be enrolled in this clinical investigation. Up to an additional 150 subjects may be enrolled under continued access. The clinical investigation will be conducted at up to 10 centers in the United States.

Subjects participating in this clinical investigation will be followed for 3 years. The expected duration of enrollment is 18 months. The total duration of the clinical investigation is expected to be 4.5 years.

Enrollment: 200 patients

Sex: All

Ages: 3+ days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of a PDA
• PDA ≤ 4mm in diameter
• PDA ≥ 3mm in length
• Subject (or legally authorized representative) is willing to comply with all pre-procedure, post-procedure, and follow-up testing requirements and provides consent to participate in the clinical study

NOTE: This study is enrolling children and all local laws and governing IRB requirements will be followed for obtaining informed consent

Exclusion criteria

• Weight < 700 grams at time of the procedure
• Age < 3 days at time of procedure
• Coarctation of the aorta
• Left pulmonary artery stenosis
• Cardiac output that is dependent on right to left shunt through the patent ductus arteriosus due to pulmonary hypertension
• Intracardiac thrombus
• Active infection requiring treatment at the time of implant
• Female subjects of child bearing potential are either pregnant or desire to become pregnant within six months post implant
• Other disease process likely to limit survival to less than six (6) months
• Participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

PDA closure

Experimental group

Treatment:

Device: ADO II AS (PDA closure)