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Registry on WATCHMAN Outcomes in Real-Life Utilization

NCT01972282 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1025

Last updated 2019-05-07

Study results available
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Summary

The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism. The objectives of this observational, prospective, non-randomized multicenter study are (1) to compile real-world clinical outcomes data for WATCHMAN LAA (left atrial appendage) Close Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect real-world usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.

Conditions

  • Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke

Interventions

DEVICE

WATCHMAN Left Atrial Appendage Closure

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Lucas VA Boersma · St. Antonius Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-28
Primary Completion
2015-11-30
Completion
2018-01-04

Countries

  • Belgium
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • Saudi Arabia
  • Spain
  • United Arab Emirates
  • United Kingdom

Study Locations

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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 NCT01972282 on ClinicalTrials.gov