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AMPLATZER Cardiac Plug Clinical Trial

NCT01118299 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2020-04-14

Study results available
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Summary

The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to the primary effectiveness endpoint and superior to OMT with respect to primary safety endpoint.

Conditions

Interventions

DEVICE

AMPLATZER Cardiac Plug

AMPLATZER Cardiac Plug is a percutaneous transcatheter device

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-26
Primary Completion
2018-12-06
Completion
2018-12-06
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01118299 on ClinicalTrials.gov