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CHAMPION-AF Clinical Trial

NCT04394546 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2026-05-14

No results posted yet for this study

Summary

The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

Conditions

Interventions

DEVICE

WATCHMAN FLX LAAC Device

WATCHMAN FLX LAAC Device Implantation

DRUG

Non-Vitamin K Oral Anticoagulant

Initiation or continuation of a NOAC drug

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Marty Leon, MD · New York-Presbyterian Heart Valve Center/Columbia University Irving Medical Center

  • Kenneth A Ellenbogen, MD · Virginia Commonwealth University

  • Shephal Doshi, MD · Pacific Heart Institute and Providence St. John's Health Center

  • Saibal Kar, MD · HCA Healthhcare /Los Robles Health System

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Saudi Arabia
  • Spain
  • Switzerland
  • 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 NCT04394546 on ClinicalTrials.gov