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Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology

NCT02702271 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2022-06-14

Study results available
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Summary

The study is a prospective, non-randomized, multi-center investigation to establish the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are eligible for long-term anti-coagulation therapy to reduce the risk of stroke but who have a rationale to seek a non-pharmacologic alternative.

Conditions

Interventions

DEVICE

WATCHMAN FLX

Left atrial appendage closure with WATCHMAN FLX

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Shephal Doshi, MD · St. John's Health Center

  • Saibal Kar, MD · Los Robles Regional Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2020-01-28
Completion
2021-03-12
FDA Device
Yes

Countries

  • United States

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 NCT02702271 on ClinicalTrials.gov