ClinicalTrials.gov record NCT07711327

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study follows people with certain blood cancers who are newly starting Bruton's tyrosine kinase inhibitor (BTKI) therapy or a non-BTKI cancer therapy. Participants are offered a smartwatch for continuous rhythm monitoring and may receive a 14-day ECG patch six months after starting therapy if atrial fibrillation (AF) has not already been detected. The study compares how often AF and other arrhythmias occur between the BTKI and non-BTKI groups and records related clinical events over 12 months.

What it is studying. The study tests how often atrial fibrillation and other heart rhythm problems are detected by smartwatch and ECG patch monitoring in people with CLL, WM, MCL, or MZL starting BTKI versus non‑BTKI therapy, and whether AF is associated with changes in cancer treatment or with bleeding, stroke, hospital visits, cardiology referrals, or survival over 12 months.

What the researchers hope to learn. Measure the incidence of new atrial fibrillation detected by smartwatch and 14‑day ECG patch; quantify AF burden on BTKI therapy; measure incidence of other arrhythmias; identify AF diagnosed in routine clinical care but not detected by device monitoring; document BTKI interruptions, dose reductions, or discontinuations attributed to arrhythmia; count hospital admissions for arrhythmia, new hypertension diagnoses, prescriptions related to AF management, major bleeding events, major adverse cardiovascular events (MACE), referrals to cardiology/electrophysiology, and overall survival at 12 months.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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

Exclusion criteria

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will be people newly starting either a Bruton's tyrosine kinase inhibitor (BTKI) or a non-BTKI cancer therapy. At enrollment you will be offered a smartwatch to monitor your heart continuously; if atrial fibrillation (AF) has not been detected, you will receive a 14-day ECG patch monitor about 6 months after starting therapy. Researchers will follow you for up to 12 months, using the smartwatch and patch data plus review of your medical record to track treatment changes (pauses, dose reductions, or stopping therapy), new diagnoses, hospital admissions, prescriptions, bleeding events, cardiovascular events, and survival. The registry record does not list other invasive procedures beyond the smartwatch and ECG patch monitoring.

How the study is structured. A prospective observational cohort study with two groups: people newly started on BTKI therapy and similar people started on non‑BTKI therapy. Participants are offered a smartwatch at enrollment for ongoing monitoring; if AF has not been found earlier, a clinically indicated 14‑day ECG patch is used six months after starting therapy. Researchers follow participants for up to 12 months and compare incidence and burden of AF and other arrhythmias, plus clinical events and treatment changes between the groups. This is not a randomized trial.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Waldenström macroglobulinemia

Clinical trials63 trials listed for Waldenström macroglobulinemiaEvery trial the registry lists for Waldenström macroglobulinemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Waldenström macroglobulinemia researchLatest monthly update: September 2026. Includes: Upfront treatment outcomes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
August 2026 (estimated)
Primary completion
August 2031 (estimated)
Study completion
August 2031 (estimated)
Target enrollment
500 participants (estimated)
Last updated on registry
Jul 17, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Tina Baykaner

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (3)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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