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Atrial Fibrillation (AF)NCT07711327

Atrial Fibrillation Among Patients With Hematologic Malignancies on Tyrosine Kinase Inhibitor Therapy

An observational study of Atrial Fibrillation (AF) and Chronic Lymphocytic Leukemia, run by Tina Baykaner at 3 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study looks at how often atrial fibrillation (AF), an irregular heart rhythm, occurs in people with certain blood cancers who are starting a type of cancer medicine called a Bruton's tyrosine kinase inhibitor (BTKI). Read more about this study

Who is it for?
Ages 18 years and older
How many people
500 participants
Where
3 sitesUnited States
Study dates
Aug 2026to Aug 2031
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults with a diagnosis of chronic lymphocytic leukemia, Waldenstrom macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma who are being newly started on BTKI or non-BTKI therapy at Stanford University, City of Hope, or UCSD oncology clinics.

Who may be able to join

  • Age greater than 18 years
  • Diagnosis of chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL)
  • New initiation of Bruton's tyrosine kinase inhibitor (BTKI) therapy or non-BTKI therapy (eg, venetoclax based) for management of hematologic malignancy

Who cannot join

  • Prior exposure to BTKI therapy
  • History of persistent atrial fibrillation

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Study Coordinator contact

707-628-2150

danieljg@stanford.edu

United States3 sites

  • City of Hope

    Duarte, California, 91010

    Study Coordinator, 800-826-4673, jrhee@coh.org

    June-Wha Rhee, MD

  • UC San Diego Health

    San Diego, California, 92103

    Ruby Swaim, 858-246-2510, rswaim@health.ucsd.edu

    Anna Narezkina, MD

  • Stanford Health Care

    Stanford, California, 94305

    Daniel Gonzalez, MTM, 707-628-2150, danieljg@stanford.edu

    Tina Baykaner, MD

Other trials in United States

About this study

This study looks at how often atrial fibrillation (AF), an irregular heart rhythm, occurs in people with certain blood cancers who are starting a type of cancer medicine called a Bruton's tyrosine kinase inhibitor (BTKI). Researchers will follow 400 people starting BTKI therapy and compare them to 100 people with similar blood cancers who are not taking a BTKI. Participants will wear a smartwatch and, later, a heart monitor patch to check for AF and other irregular heart rhythms over 12 months. The study will also look at whether AF affects cancer treatment, such as needing to pause, lower the dose, or stop the BTKI, and whether it leads to other health problems such as bleeding, stroke, or heart-related hospital visits.

Keywords
Bruton's Tyrosine Kinase Inhibitor, BTKI, Ibrutinib, Acalabrutinib, Zanubrutinib, Cardio-oncology, ECG patch monitor, Smartwatch monitoring, Arrhythmia, Hematologic malignancy
Medical subject headings
Atrial Fibrillation, Leukemia, Lymphocytic, Chronic, B-Cell, Waldenstrom Macroglobulinemia, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Arrhythmias, Cardiac, Hematologic Neoplasms

What participants receive

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

Study groups in NCT07711327
Study groupRoleWhat they receive
BTKI TherapyParticipants with chronic lymphocytic leukemia, Waldenstrom macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma who are newly initiated on Bruton's tyrosine kinase inhibitor (BTKI) therapy. Participants are offered a smartwatch at enrollment for continuous monitoring and receive a clinically indicated ECG patch monitor 6 months after initiation of therapy if AF has not already been detected.
Non-BTKI Therapy (Control)Participants with the same hematologic malignancy diagnoses who are newly initiated on non-BTKI therapy (e.g., venetoclax-based regimens) instead of a BTKI. Participants are offered a smartwatch at enrollment for continuous monitoring and receive a clinically indicated ECG patch monitor 6 months after initiation of therapy if AF has not already been detected.

What is being measured

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

  1. Incidence of Atrial Fibrillation

    Incidence of new atrial fibrillation (AF) detected by smartwatch photoplethysmography with confirmatory ECG, and/or by 14-day ECG patch monitor, compared between participants on BTKI therapy and non-BTKI control participants.

    Measured: Up to 12 months

Secondary outcomes (11)

  1. AF Burden on BTKI Therapy

    Proportion of time spent in atrial fibrillation among participants on BTKI therapy, as determined by 14-day ECG patch monitor.

    Measured: Up to 12 months

  2. Incidence of Other Arrhythmias

    Incidence of arrhythmias other than atrial fibrillation, including premature atrial contractions (PACs), premature ventricular contractions (PVCs), non-sustained ventricular tachycardia (NSVT), supraventricular tachycardia (SVT), and atrioventricular (AV) blocks, detected by ECG patch monitor or incidental findings on ECG-enabled smartwatch recordings.

    Measured: Up to 12 months

  3. Clinical Atrial Fibrillation Diagnosis Not Detected by Smartwatch or ECG Patch Monitor

    Number of participants with new atrial fibrillation diagnosed during routine clinical care (primary care visit, emergency department, or hospitalization) that was not identified through smartwatch or ECG patch monitoring.

    Measured: Up to 12 months

  4. BTKI Therapy Interruption, Dose Reduction, or Cessation Due to Arrhythmia

    Number of participants on BTKI therapy who experience treatment interruption, dose reduction, or permanent discontinuation attributed to atrial fibrillation or other arrhythmias.

    Measured: Up to 12 months

  5. Hospital Admission for Atrial Fibrillation or Other Arrhythmias

    Number of participants hospitalized for management of atrial fibrillation or other arrhythmias.

    Measured: Up to 12 months

  6. New Clinical Diagnosis of Hypertension

    Number of participants with newly diagnosed hypertension during the study period, as documented in the electronic health record.

    Measured: Up to 12 months

  7. Prescription of Antiplatelet, Anticoagulant, or Rate/Rhythm Control Medication for Atrial Fibrillation

    Number of participants prescribed antiplatelet, anticoagulant, or rate or rhythm control medications for management of atrial fibrillation, as determined by the treating care team.

    Measured: Up to 12 months

  8. Incidence of Major Bleeding Events

    Number of participants with major bleeding events, as documented in the electronic health record.

    Measured: Up to 12 months

  9. Incidence of Major Adverse Cardiovascular Events (MACE)

    Number of participants with a major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, unplanned surgical or percutaneous coronary revascularization, hospital admission for arterial thrombosis, or heart failure.

    Measured: Up to 12 months

  10. Referral to Cardiology or Electrophysiology

    Number of participants referred to cardiology or electrophysiology for evaluation or management during the study period.

    Measured: Up to 12 months

  11. Overall Survival

    Number of participants alive at 12 months following enrollment.

    Measured: At 12 months

Timeline

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

  1. First posted17 Jul 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionAug 2031 (estimated)
  4. Study completionAug 2031 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07711327
Sponsor's protocol ID
85203
Status last verified
Jul 2026
First submitted
14 Jul 2026
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: De-identified individual participant data are not currently planned for sharing outside the study team. Data are stored in RedCap, accessible only to research team members, with participant identifiers kept separate in a password-protected code book. This plan may be revised in a future update if a formal data sharing arrangement is established.

Publications

  • Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.

    PubMed 31722151

  • Lubitz SA, Faranesh AZ, Selvaggi C, Atlas SJ, McManus DD, Singer DE, Pagoto S, McConnell MV, Pantelopoulos A, Foulkes AS. Detection of Atrial Fibrillation in a Large Population Using Wearable Devices: The Fitbit Heart Study. Circulation. 2022 Nov 8;146(19):1415-1424. doi: 10.1161/CIRCULATIONAHA.122.060291. Epub 2022 Sep 23.

    PubMed 36148649

  • Archibald WJ, Rabe KG, Kabat BF, Herrmann J, Ding W, Kay NE, Kenderian SS, Muchtar E, Leis JF, Wang Y, Chanan-Khan AA, Schwager SM, Koehler AB, Fonder AL, Slager SL, Shanafelt TD, Call TG, Parikh SA. Atrial fibrillation in patients with chronic lymphocytic leukemia (CLL) treated with ibrutinib: risk prediction, management, and clinical outcomes. Ann Hematol. 2021 Jan;100(1):143-155. doi: 10.1007/s00277-020-04094-3. Epub 2020 Jun 1.

    PubMed 32488603

  • Healey JS, Alings M, Ha A, Leong-Sit P, Birnie DH, de Graaf JJ, Freericks M, Verma A, Wang J, Leong D, Dokainish H, Philippon F, Barake W, McIntyre WF, Simek K, Hill MD, Mehta SR, Carlson M, Smeele F, Pandey AS, Connolly SJ; ASSERT-II Investigators. Subclinical Atrial Fibrillation in Older Patients. Circulation. 2017 Oct 3;136(14):1276-1283. doi: 10.1161/CIRCULATIONAHA.117.028845. Epub 2017 Aug 4.

    PubMed 28778946

  • Svendsen JH, Diederichsen SZ, Hojberg S, Krieger DW, Graff C, Kronborg C, Olesen MS, Nielsen JB, Holst AG, Brandes A, Haugan KJ, Kober L. Implantable loop recorder detection of atrial fibrillation to prevent stroke (The LOOP Study): a randomised controlled trial. Lancet. 2021 Oct 23;398(10310):1507-1516. doi: 10.1016/S0140-6736(21)01698-6. Epub 2021 Aug 29.

    PubMed 34469766

  • Gladstone DJ, Wachter R, Schmalstieg-Bahr K, Quinn FR, Hummers E, Ivers N, Marsden T, Thornton A, Djuric A, Suerbaum J, von Grunhagen D, McIntyre WF, Benz AP, Wong JA, Merali F, Henein S, Nichol C, Connolly SJ, Healey JS; SCREEN-AF Investigators and Coordinators. Screening for Atrial Fibrillation in the Older Population: A Randomized Clinical Trial. JAMA Cardiol. 2021 May 1;6(5):558-567. doi: 10.1001/jamacardio.2021.0038.

    PubMed 33625468

  • Leong DP, Caron F, Hillis C, Duan A, Healey JS, Fraser G, Siegal D. The risk of atrial fibrillation with ibrutinib use: a systematic review and meta-analysis. Blood. 2016 Jul 7;128(1):138-40. doi: 10.1182/blood-2016-05-712828. Epub 2016 May 31. No abstract available.

    PubMed 27247135

  • Ganatra S, Sharma A, Shah S, Chaudhry GM, Martin DT, Neilan TG, Mahmood SS, Barac A, Groarke JD, Hayek SS, Dani S, Venesy D, Patten R, Nohria A. Ibrutinib-Associated Atrial Fibrillation. JACC Clin Electrophysiol. 2018 Dec;4(12):1491-1500. doi: 10.1016/j.jacep.2018.06.004. Epub 2018 Aug 29.

    PubMed 30573111

  • Wei C, Fazal M, Loh A, Kapoor R, Gomez SE, Shah S, Rogers AJ, Narayan SM, Wang PJ, Witteles RM, Perino AC, Cheng P, Rhee JW, Baykaner T. Comparative arrhythmia patterns among patients on tyrosine kinase inhibitors. J Interv Card Electrophysiol. 2024 Jan;67(1):111-118. doi: 10.1007/s10840-023-01575-z. Epub 2023 May 31.

    PubMed 37256462

  • Wiczer TE, Levine LB, Brumbaugh J, Coggins J, Zhao Q, Ruppert AS, Rogers K, McCoy A, Mousa L, Guha A, Heerema NA, Maddocks K, Christian B, Andritsos LA, Jaglowski S, Devine S, Baiocchi R, Woyach J, Jones J, Grever M, Blum KA, Byrd JC, Awan FT. Cumulative incidence, risk factors, and management of atrial fibrillation in patients receiving ibrutinib. Blood Adv. 2017 Sep 8;1(20):1739-1748. doi: 10.1182/bloodadvances.2017009720. eCollection 2017 Sep 12.

    PubMed 29296820

  • Fazal M, Kapoor R, Cheng P, Rogers AJ, Narayan SM, Wang P, Witteles RM, Perino AC, Baykaner T, Rhee JW. Arrhythmia Patterns in Patients on Ibrutinib. Front Cardiovasc Med. 2022 Jan 3;8:792310. doi: 10.3389/fcvm.2021.792310. eCollection 2021.

    PubMed 35047578

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation (AF) and Chronic Lymphocytic Leukemia, run by Tina Baykaner at 3 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 2 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: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Study Coordinator (707-628-2150, danieljg@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Atrial Fibrillation (time frame: Up to 12 months). 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 NCT07711327, which also lists 11 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 17 Jul 2026.

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