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Atrial FibrillationPhase 4GUARD-AFNCT04126486

A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke

A Phase 4 study testing Zio®XT Monitor in people with Atrial Fibrillation and Atrial Flutter, run by Bristol-Myers Squibb at 176 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention). Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Atrial Fibrillation, Atrial Flutter
What is being tested?
Zio®XT Monitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11,931 participants
Where
176 sitesUnited States
Study dates
17 Dec 2019to 30 Jun 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Men and women at least 70 years of age who are new or established participants in the primary care practice
  • Willing to provide consent to participate in the study and to use personal health information to ascertain endpoints from the Center for Medicare \& Medicaid Services (CMS) Medicare Claims Database and to access data from health records
  • Health insurance by Medicare Parts A \& B (Medicare Fee-for-service)

Who cannot join

  • Oral anticoagulation (OAC) for any indication at the time of enrollment
  • History of Atrial Fibrillation (AF) or Atrial Flutter (AFL) as documented in the participant's current medical problem list
  • Any condition the investigator considers a contraindication to OAC, e.g., bleeding that required medical attention or severe renal impairment
  • Any condition the investigator considers will prevent compliance with study instructions
  • Implanted cardiac devices (pacemakers, implantable cardiac defibrillators, or cardiac resynchronization therapy, and implantable loop recorders)
  • History of allergy to adhesive
  • Not able to wear the Zio®XT monitor or not able to apply the monitor by herself/himself or with the help of a caregiver
  • Other protocol-defined inclusion/exclusion criteria could apply

Trial locations and contacts

176 sites in 1 country.

176 sites in 1 country

United States176 sites

  • Local Institution - 0263

    Albany, Georgia, 31701

  • Wellness Clinical Research

    Allen, Texas, 75013

  • Local Institution - 0338

    Ames, Iowa, 50010

  • Local Institution - 0351

    Annapolis, Maryland, 21401

  • Local Institution - 0339

    Appomattox, Virginia, 24522

  • Local Institution - 0027

    Atlanta, Georgia, 30345

  • Local Institution - 0187

    Austin, Texas, 78731

  • Local Institution - 0243

    Austin, Texas, 78745

  • Local Institution

    Aventura, Florida, 33180

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • Belzoni Family Practice

    Belzoni, Mississippi, 39038

  • Local Institution - 0302

    Birmingham, Alabama, 35209

  • Local Institution

    Black Mountain, North Carolina, 28711

  • Local Institution - 0284

    Boston, Massachusetts, 02114

  • Local Institution - 0051

    Boston, Massachusetts, 02115

  • Local Institution - 0150

    Bountiful, Utah, 84010

  • Local Institution - 0143

    Boynton Beach, Florida, 33435

  • Local Institution - 0155

    Bristol, Tennessee, 37620

  • Local Institution - 0249

    Brooklyn, New York, 11229

  • Local Institution - 0191

    Burke, Virginia, 22015

  • Local Institution - 0328

    Burlington, North Carolina, 27215

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Local Institution - 0260

    Caro, Michigan, 48723

  • Local Institution - 0164

    Cary, North Carolina, 27615

  • PMG Research of Charlotte, LLC

    Charlotte, North Carolina, 28209

  • Local Institution - 0207

    Charlotte, North Carolina, 28287

  • Local Institution - 0311

    Chicago, Illinois, 60637

  • Sterling Research Group

    Cincinnati, Ohio, 45219

  • Local Institution - 0085

    Cincinnati, Ohio, 45246

  • Local Institution - 0232

    Clearwater, Florida, 33756-2004

  • Local Institution - 0017

    Clearwater, Florida, 33761

  • Local Institution - 0283

    Cleveland, Ohio, 44195

  • Local Institution

    Columbus, Georgia, 31904

  • Local Institution - 0036

    Columbus, Ohio, 43213-3399

  • Local Institution - 0362

    Cooperstown, New York, 13326

  • HRMD Research

    Dallas, Texas, 75240

  • Dayton Clinical Research

    Dayton, Ohio, 45406

  • Local Institution - 0212

    Dayton, Ohio, 45419

  • Local Institution - 0062

    DeLand, Florida, 32720

  • University Clinical Research-Deland LLC dba Accel Research Sites

    DeLand, Florida, 32720

  • Local Institution - 0242

    Denton, Texas, 76210

  • Local Institution - 0005

    Detroit, Michigan, 48216

  • Local Institution - 0350

    Doral, Florida, 33166

  • Local Institution - 0006

    Durham, North Carolina, 27701

  • Local Institution - 0240

    East Providence, Rhode Island, 02914

  • Local Institution

    East Syracuse, New York, 13057

  • Local Institution - 0033

    Eatonton, Georgia, 31024

  • Local Institution - 0337

    Eau Claire, Wisconsin, 54703

  • Invesclinic.U.S,LLC

    Edinburg, Texas, 78539

  • Local Institution - 0037

    Elkridge, Maryland, 21075

  • Local Institution - 0102

    Endwell, New York, 13760

  • Local Institution - 0133

    Eunice, Louisiana, 70535

  • Local Institution - 0086

    Everett, Washington, 98208

  • Local Institution - 0345

    Evergreen Park, Illinois, 60805

  • Local Institution - 0176

    Fayetteville, Georgia, 30214

  • Local Institution

    Fayetteville, North Carolina, 28304-3571

  • Local Institution - 0340

    Forest, Virginia, 24551

  • Local Institution - 0367

    Fort Lauderdale, Florida, 33073

  • Local Institution - 0161

    Fort Lauderdale, Florida, 33308

  • Vanguard Clinical Research, LLC

    Fort Myers, Florida, 33907

  • Local Institution - 0268

    Franklinton, North Carolina, 27525

  • Local Institution - 0173

    Fremont, California, 94538

  • Local Institution - 0141

    Friendswood, Texas, 77546

  • Local Institution - 0110

    Fullerton, California, 92831

  • Local Institution - 0354

    Georgetown, Texas, 78628

  • Local Institution - 0241

    Gillespie, Illinois, 62033

  • Finlay Medical Research Corp

    Greenacres City, Florida, 33467

  • Local Institution - 0258

    Greensboro, North Carolina, 27408

  • Local Institution - 0360

    Guntersville, Alabama, 35976

  • Local Institution - 0333

    Haverhill, Massachusetts, 01830

  • Local Institution - 0222

    Henderson, Nevada, 89014

  • Local Institution - 0348

    Hialeah, Florida, 33012

  • Local Institution - 0358

    Hialeah, Florida, 33015

  • Local Institution - 0219

    Hialeah, Florida, 33016

  • Local Institution - 0159

    Hickory, North Carolina, 28601

  • Local Institution - 0011

    Houston, Texas, 77070

  • Local Institution - 0343

    Houston, Texas, 77095

  • Local Institution - 0016

    Hurst, Texas, 76054-3351

  • Local Institution - 0365

    Indianapolis, Indiana, 46202

  • University of Iowa

    Iowa City, Iowa, 52242

  • Local Institution - 0089

    Jackson, Mississippi, 39209

  • Local Institution - 0366

    Jacksonville, Florida, 32204

  • Local Institution - 0368

    Jacksonville, Florida, 32216

  • Local Institution - 0277

    Jacksonville, Florida, 32224

  • Local Institution - 0109

    Kingman, Arizona, 86409

  • Local Institution - 0234

    Knoxville, Tennessee, 37912

  • Local Institution - 0335

    La Crosse, Wisconsin, 54601

  • Local Institution - 0375

    Lake City, Florida, 32055-4833

  • Local Institution - 0151

    Laredo, Texas, 78041

  • Local Institution

    Las Vegas, Nevada, 89109

  • Local Institution - 0369

    Lexington, Kentucky, 40504

  • Local Institution - 0334

    Linden, New Jersey, 07036

  • Local Institution - 0097

    Little Rock, Arkansas, 72204

  • Local Institution - 0288

    Madison, Wisconsin, 53715

  • Local Institution - 0331

    Matthews, North Carolina, 28105

  • Local Institution - 0170

    Mesquite, Texas, 75149

  • Nova Clinical Research Center Inc

    Miami, Florida, 33125

  • Local Institution - 0025

    Miami, Florida, 33144

  • Local Institution - 0296

    Miami, Florida, 33144

  • Local Institution

    Miami, Florida, 33155

  • Local Institution

    Miami, Florida, 33165

  • Local Institution - 0300

    Miami, Florida, 33174

  • Local Institution - 0371

    Miami, Florida, 33175

  • Local Institution

    Miami, Florida, 33176

  • Local Institution - 0149

    Miami Beach, Florida, 33140

  • Local Institution - 0374

    Miami Lakes, Florida, 33014

  • Local Institution - 0372

    Miami Shores, Florida, 33138

  • Local Institution - 0254

    Michigan City, Indiana, 46360-9330

  • Local Institution - 0158

    Montgomery, Alabama, 36106

  • Local Institution - 0324

    Morristown, Tennessee, 37813

  • Local Institution - 0010

    Mt. Dora, Florida, 32757-9519

  • Local Institution - 0309

    Nashville, Tennessee, 37212

  • Local Institution - 0201

    New Bedford, Massachusetts, 02740

  • Local Institution - 0321

    New Orleans, Louisiana, 70121

  • Local Institution - 0379

    Niagara Falls, New York, 14304

  • Local Institution - 0063

    Norfolk, Nebraska, 68701

  • Digiovanna Institute For Medical Education

    North Massapequa, New York, 11758

  • Local Institution - 0301

    Oakland, California, 94612

  • Local Institution - 0058

    Oviedo, Florida, 32765-4515

  • Local Institution - 0132

    Palm Harbor, Florida, 34684

  • Local Institution - 0034

    Palm Springs, Florida, 33406

  • Local Institution - 0101

    Pearland, Texas, 77584-7401

  • Local Institution - 0047

    Peoria, Arizona, 85381

  • Local Institution - 0237

    Peoria, Arizona, 85381

  • Local Institution - 0224

    Petal, Mississippi, 39465

  • Local Institution - 0223

    Pflugerville, Texas, 78660

  • Local Institution - 0303

    Pharr, Texas, 78577

  • Local Institution - 0129

    Philadelphia, Pennsylvania, 19107

  • Local Institution - 0171

    Phoenix, Arizona, 85004

  • Local Institution - 0271

    Phoenix, Arizona, 85051

  • Local Institution - 0060

    Picayune, Mississippi, 39466

  • Local Institution - 0272

    Pittsburgh, Pennsylvania, 15208

  • Local Institution - 0236

    Pittsburgh, Pennsylvania, 15236-4604

  • Local Institution - 0349

    Pittsburgh, Pennsylvania, 15243

  • Local Institution - 0204

    Plano, Texas, 75025

  • Local Institution - 0067

    Plano, Texas, 75093

  • Local Institution - 0230

    Raleigh, North Carolina, 27609

  • Quinn Healthcare/SKYCRNG

    Ridgeland, Mississippi, 39157

  • Local Institution - 0214

    Rincon, Georgia, 31406

  • Local Institution - 0256

    Rochester, Minnesota, 55905-0001

  • Local Institution - 0095

    Rockville, Maryland, 20854

  • Local Institution - 0175

    Rocky Mount, North Carolina, 27804

  • Local Institution - 0248

    Sacramento, California, 95821-2640

  • Local Institution - 0253

    Salisbury, North Carolina, 28144

  • SA Premiere Internal Medicine

    San Antonio, Texas, 78220-2531

  • Local Institution - 0092

    San Antonio, Texas, 78249

  • Local Institution - 0278

    San Marcos, Texas, 78666-7579

  • Local Institution - 0098

    Savannah, Georgia, 31406

  • Local Institution - 0116

    St Louis, Missouri, 63123

  • Local Institution - 0153

    Statesville, North Carolina, 28625

  • Local Institution - 0182

    Statesville, North Carolina, 28625

  • Local Institution - 0166

    Sterling Heights, Michigan, 48310

  • Local Institution - 0267

    Suffolk, Virginia, 23435

  • Local Institution - 0055

    Sugar Land, Texas, 77479

  • Local Institution - 0137

    Sugar Land, Texas, 77479

  • Local Institution - 0299

    Tacoma, Washington, 98498

  • Local Institution - 0028

    Tampa, Florida, 33613

  • Local Institution - 0090

    Tampa, Florida, 33615

  • Local Institution - 0251

    The Woodlands, Texas, 77382

  • Local Institution - 0147

    The Woodlands, Texas, 77384

  • Local Institution - 0061

    Toluca Lake, California, 91602

  • Local Institution - 0257

    Troy, Michigan, 48085

  • Local Institution - 0322

    Tyler, Texas, 75702

  • Local Institution - 0347

    Uniontown, Pennsylvania, 15401

  • Local Institution - 0370

    Uniontown, Pennsylvania, 15401

  • Local Institution - 0306

    Wauconda, Illinois, 60084

  • Local Institution - 0361

    Weston, Florida, 33326

  • Local Institution - 0244

    Wichita, Kansas, 67214

  • Local Institution - 0235

    Wilmington, North Carolina, 28401-7307

  • Local Institution - 0096

    Winchester, Virginia, 22601

  • Local Institution - 0364

    Winchester, Virginia, 22601

  • Local Institution - 0167

    Winston-Salem, North Carolina, 27103-4109

  • Local Institution - 0123

    Woodstock, Georgia, 30189

  • Local Institution - 0227

    Worcester, Massachusetts, 01655

  • Local Institution - 0323

    Yuma, Arizona, 85364

  • Local Institution - 0229

    Zachary, Louisiana, 70791-4006

Other trials in United States

About this study

Official title: GUARD-AF: reducinG Stroke by Screening for UndiAgnosed atRial Fibrillation in Elderly inDividuals

The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).

Read the detailed description

This a prospective, randomized study in primary care practices.

Being tested
Zio®XT Monitor
Medical subject headings
Atrial Fibrillation, Atrial Flutter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zio®XT MonitorOther

    A Zio® XT monitor will be affixed to the participant's chest

Study groups in NCT04126486
Study groupRoleWhat they receive
Zio®XT Monitor ArmOtherNot described
Receives: Other: Zio®XT Monitor
Usual Care ArmNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of all strokes leading to hospitalization

    Measured: From 2.5 years to 5 years after study start

  2. Incidence of bleeding leading to hospitalization

    Measured: From 2.5 years to 5 years after study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2019
  2. Study start17 Dec 2019
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
11,931 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04126486
Sponsor's protocol ID
CV185-749
Acronym
GUARD-AF
Status last verified
Jul 2023
First submitted
11 Oct 2019
Last updated
12 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Singer DE, Atlas SJ, Go AS, Lubitz SA, McManus DD, Dolor RJ, Chatterjee R, Rothberg MB, Rushlow DR, Crosson LA, Aronson RS, Mills D, Patlakh M, Gallup D, O'Brien EC, Lopes RD. Atrial Fibrillation Burden on a 14-Day ECG Monitor: Findings From the GUARD-AF Trial Screening Arm. JACC Clin Electrophysiol. 2025 Jan;11(1):110-119. doi: 10.1016/j.jacep.2024.08.010. Epub 2024 Sep 1.

    PubMed 39297839

  • Lopes RD, Atlas SJ, Go AS, Lubitz SA, McManus DD, Dolor RJ, Chatterjee R, Rothberg MB, Rushlow DR, Crosson LA, Aronson RS, Patlakh M, Gallup D, Mills DJ, O'Brien EC, Singer DE. Effect of Screening for Undiagnosed Atrial Fibrillation on Stroke Prevention. J Am Coll Cardiol. 2024 Nov 19;84(21):2073-2084. doi: 10.1016/j.jacc.2024.08.019. Epub 2024 Sep 1.

    PubMed 39230544

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zio®XT Monitor in people with Atrial Fibrillation and Atrial Flutter, run by Bristol-Myers Squibb at 176 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of all strokes leading to hospitalization (time frame: From 2.5 years to 5 years after study start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04126486, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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