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NCT04394546 · ClinicalTrials.gov registry record · NA

CHAMPION-AF Clinical Trial

A NA study of Stroke and Atrial Fibrillation, sponsored by Boston Scientific Corporation.

Active
Registry status
NA
Development phase
3,000
Enrollment target
20
Study locations

NCT04394546: Active NA study of Stroke and Atrial Fibrillation, sponsored by Boston Scientific Corporation.

NCT04394546 is a NA study of Stroke and Atrial Fibrillation that is active but no longer recruiting, run by Boston Scientific Corporation. The registered enrollment target is 3,000 participants, below the 12,010-participant average among 454 other Stroke trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04394546, a NA study of Stroke and Atrial Fibrillation, is active but no longer recruiting, sponsored by Boston Scientific Corporation.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
3,000 participants
Enrollment target
20
Study locations

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.

Primary Outcome

non-inferiority

Interventions

  • DEVICE WATCHMAN FLX LAAC Device
  • DRUG Non-Vitamin K Oral Anticoagulant

Study Locations (20)

California

  • Sharp Chula Vista Medical Center - Chula Vista
  • Marin General Hospital - Greenbrae
  • Scripps Memorial Hospital - La Jolla
  • Los Robles Hospital and Medical Center - Los Angeles
  • El Camino Hospital - Mountain View
  • Eisenhower Medical Center - Rancho Mirage
  • Mercy General Hospital - Sacramento
  • Santa Barbara Cottage Hospital - Santa Barbara
  • St. John's Health Center - Santa Monica

Arizona

  • Arizona Arrhythmia Research Center - Phoenix
  • Phoenix Cardiovascular Research Group - Phoenix
  • Scottsdale Healthcare - Shea - Scottsdale
  • Tucson Medical Center Healthcare - Tucson

Alabama

  • Grandview Medical Center - Birmingham
  • University of Alabama at Birmingham - Birmingham

Arkansas

  • Arrythmia Research Group - Jonesboro

Colorado

  • Colorado Springs Cardiologist, P.C. - Colorado Springs

Connecticut

  • Yale University School of Medicine - New Haven

Delaware

  • Christiana Hospital - Newark

District of Columbia

  • Washington Hospital Center - Washington D.C.

Trial Details

FieldValue
Enrollment Target 3,000 participants
Start Date 2020-10-15
Est. Completion 2027-12
Phase NA
Boston Scientific Corporation

280 total trials

What the registry record for NCT04394546 still lists

NCT04394546 is an interventional study that assigns participants to a tested intervention. Its 3,000 participants enrollment target places it among the larger protocols in the corpus, below the 12,010-participant average among 454 other Stroke trials with a reported enrollment target (75% lower).

The record links to 3 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which WATCHMAN FLX LAAC Device is the first listed.

NCT04394546 names 20 study sites across 8 states, led by California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT04394546 about?

NCT04394546 is a clinical study titled "CHAMPION-AF Clinical Trial". 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.

What is the current status of trial NCT04394546?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 3,000 participants. The study started on 2020-10-15. Estimated completion is 2027-12.

What conditions does trial NCT04394546 study?

This clinical trial studies the following conditions: Stroke, Atrial Fibrillation, Bleeding.

What interventions are being tested in trial NCT04394546?

The interventions under investigation include: WATCHMAN FLX LAAC Device (DEVICE), Non-Vitamin K Oral Anticoagulant (DRUG).

Who is sponsoring clinical trial NCT04394546?

This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04394546 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stroke

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04394546's enrollment target sits among peer trials

3,000 22nd of 454 higher than 432 of 454 other Stroke trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04394546, the US trial registry maintained by the National Library of Medicine. NCT04394546 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.