AMPLATZER Duct Occluder II Clinical Study (ADO II)

Abbott

Status: Completed

Conditions: Patent Ductus Arteriosus

Treatments: Device: AMPLATZER Duct Occluder II

Study type: Interventional

Funder types: Industry

Identifiers

NCT00713700

CL00233

Details and patient eligibility

About

The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.

Enrollment: 192 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must have diagnosis of a PDA
• Subject must have a PDA < 5.5mm in diameter by angiography
• Subject must have a PDA < 12mm in length by angiography
• Subject must have a PDA > 3mm in length by angiography
• Subject/legally authorized representative must give consent to participate in the clinical study
• Subject/legally authorized representative must consent to follow-up for the duration of the clinical study

Exclusion criteria

• Subject must not be < 6 kilograms for the procedure

• Subject must not be < 6 months of age

• Subject must not be ≥ 18 years of age

• Subject must not have a descending aorta < 10mm in diameter

• Subject must not have a right to left shunt through the patent ductus arteriosus

• Subject must not have PVR above 8 Woods units or a Rp/Rs >0.4

• Subject must not have intracardiac thrombus

• Subject must not have additional cardiac anomalies requiring surgical or interventional correction

• Subject must not have history of more than two lower respiratory infections within the last year (i.e., pneumonia)

• Subject must not have active infection requiring treatment at the time of implant

• Subject must not have contraindication to anticoagulation treatment

• Female subjects of child bearing age must not be pregnant or desire to become pregnant within six months post implant*

• Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints

  • If the subject desires to become pregnant after six months post-implant, further restriction is at the discretion of their physician.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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192 participants in 1 patient group

Device

Experimental group

Treatment:

Device: AMPLATZER Duct Occluder II