AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational "ACP LA"

Withdrawn

Phase N/A Results N/A

Trial Description

The ACP device will be clinically evaluated through a prospective, open-label, nonrandomized, multi-center post market clinical study.

Trial Stopped: St. Jude Medical business decision

Conditions

Interventions

Trial Design

  • Observation: Case-Only
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Subjects with nonvalvular atrial fibrillation (NVAF)

Outcomes

Type Measure Time Frame Safety Issue
Primary Evaluate the performance of the ACP device in closure of the LAA 2 years post implant No
Primary The rate of occurrence for any reported adverse event experienced by subjects enrolled Through 2 years Yes

Sponsors