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CHAMPION-AF Clinical Trial
NCT04394546 · View on ClinicalTrials.gov ↗
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 Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 3,000 participants |
| Start Date | 2020-10-15 |
| Est. Completion | 2027-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04394546
The ClinicalTrials.gov registry entry for NCT04394546 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04394546 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04394546?
The interventions under investigation include: WATCHMAN FLX LAAC Device (DEVICE), Non-Vitamin K Oral Anticoagulant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04394546?
This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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