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Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)

NCT02447081 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1088

Last updated 2019-12-30

Study results available
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Summary

This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."

Conditions

Interventions

DEVICE

Subjects implanted with Amulet Device

Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • David Hildick-Smith, MD · Brighton and Sussex University Hospitals

  • Claudio Tondo, MD PhD · University of Milan

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2018-10-23
Completion
2018-10-23

Countries

  • Australia
  • Belgium
  • Chile
  • Denmark
  • Finland
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden
  • United Kingdom

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 NCT02447081 on ClinicalTrials.gov