CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,025 enrolled
Drug / intervention
WATCHMAN Left Atrial Appendage Closuredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01972282
NCT01972282N/ACompleted

Registry on WATCHMAN Outcomes in Real-Life Utilization

Boston Scientific Corporation·observational·Posted Oct 30, 2013·Updated May 7, 2019

In Brief

An observational study evaluating WATCHMAN Left Atrial Appendage Closure for Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke. Completed, enrolled 1,025 participants across 47 sites in 13 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France, Germany, Ireland, Italy, Netherlands, Poland, Portugal, Russia, Saudi Arabia, Spain, United Arab Emirates, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 30, 2013
Enrollment StartOct 28, 2013
Primary CompletionNov 1, 2015
Study CompletionJan 4, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 12.7 years ago

Interventions

WATCHMAN Left Atrial Appendage Closuredevice