AMPLATZER Cardiac Plug (ACP) Registry-Long Term Follow-up Protocol "ACPR"

Completed

Phase N/A Results N/A

Trial Description

The objective of the AMPLATZER Cardiac Plug (ACP) Registry Long Term Follow-up study is to evaluate long term performance of the ACP in closure of the Left Atrial Appendage (LAA) in subjects with nonvalvular atrial fibrillation and assess adverse events up to two (2) or more years post implant.

Conditions

Interventions

Trial Design

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

Trial Population

Patients with non-valvular atrial fibrillation

Outcomes

Type Measure Time Frame Safety Issue
Primary The rate of occurrence for any reported adverse event experienced by subjects enrolled. Through 2 years Yes
Primary Closure 6 months No
Primary Technical success At implant No

Sponsors