Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

NCT04371081 | Active Not Recruiting

• 1 other identifier: ABT-CIP-10290
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this post-marketing clinical use database surveillance is to observe the frequency, type, and degree of adverse device effects and adverse events in order to assure the safety of the medical device, and to collect safety and efficacy information for evaluating the results of its clinical use.

Conditions

Patent Ductus Arteriosus

Outcome Measures

Primary Outcomes (2)

• The rate of major complications through 180 days after an attempted Piccolo device implant

  Through 180 days after an attempted Piccolo device implant

• The rate of effective closure of the ductus arteriosus among subjects with a successful Piccolo implant as assessed by the presence of either a Grade 0 or Grade 1 shunt at the 6-month follow-up by transthoracic echocardiography

  At the 6-month follow-up

Study Arms (1)

Amplatzer Piccolo Occluder

Amplatzer Piccolo Occluder device implant

Device: Amplatzer Piccolo Occluder

Interventions

Amplatzer Piccolo Occluder DEVICE

Interventional placement of vascular occluder

Amplatzer Piccolo Occluder

Eligibility Criteria

• Age: 3 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with patent ductus arteriosus (PDA) in whom an Amplatzer™ Piccolo Occluder (Piccolo) implant was attempted will be included in this registry.

You may qualify if:

• The device is used to percutaneously close the PDA of a patient who meets all of the following:
• PDA ≤4 mm in diameter
• PDA ≥3 mm in length
• Weight ≥700 g

You may not qualify if:

• Age \<3 days
• Coarctation of the aorta
• Left pulmonary artery stenosis
• Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension
• Thrombus in the implant site, or sign of venous thrombus in a vessel in which the occluder is inserted and delivered
• Endocarditis, or infection that can cause bacteremia
• Allergic or potentially allergic to nickel

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Japanese society of Congenital Interventional Cardiology: collaborator

Study Sites (1)

Showa University Hospital

Tokyo, Japan

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 1, 2020
• Study Start: April 1, 2020
• Primary Completion: September 10, 2025
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-10

Locations

JP (1)