NCT03055858

AMPLATZER Duct Occluder II Additional Sizes

AMPLATZER Duct Occluder II Additional Sizes Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 3 Days
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DEVICE	ADO II AS (PDA closure)	Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).

Timeline

• Start date: 2017-06-05
• Primary completion: 2019-09-25
• Completion: 2022-04-05
• First posted: 2017-02-16
• Last updated: 2025-02-11
• Results posted: 2020-10-05

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study