Trials
Search / Trial NCT05643235

Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors

Launched by NORTHWELL HEALTH · Dec 1, 2022

Trial Information

Current as of January 14, 2025

Recruiting

Keywords

Bruton Tyrosine Kinase (Btk) Chronic Lymphocytic Leukemia (Cll) Mantle Cell Lymphoma Waldenstrom's Macroglobulinemia Atrial Fibrillation (Af) Ventricular Arrhythmia (Va) Sudden Cardiac Death Ibrutinib Acalabrutinib Zanubrutinib Pirtobrutinib Implanted Loop Recorder/Implanted Cardiac Monitor (Ilr)

ClinConnect Summary

This clinical trial is exploring how well a special heart monitor, called the Medtronic LINQ-2 insertable cardiac monitor, can help detect heart rhythm problems (known as arrhythmias) in patients starting treatment with a medication called Bruton Tyrosine Kinase (BTK) inhibitors. These medications are often used for certain types of blood cancers like chronic lymphocytic leukemia. The study aims to find out how many patients experience new heart rhythm issues while on this treatment, and what actions are taken when these issues are detected.

To be eligible for the trial, participants must be at least 18 years old and starting a BTK inhibitor without a recent history of heart rhythm problems. They should also be willing to have the heart monitor implanted for at least 24 hours to track their heart activity. Participants can expect regular remote monitoring to check for any new arrhythmias during their treatment. It's important to note that individuals with certain health issues, such as recent heart attacks or strokes, or those already using specific heart devices, cannot take part in the study. Overall, this trial aims to enhance our understanding of heart health in patients receiving BTK inhibitors, which could lead to better care and management of any arising heart problems.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • \>18yo
  • Willing to sign and date consent form,
  • Willing to be remotely monitored
  • Initiating BTK inhibitor for approved condition (i.e. CLL, Waldenstrom's, etc)
  • Willing to have Medtronic cardiac monitor inserted to allow at minimum 24 hours continuous monitoring prior to initiating BTK inhibitor
  • Exclusion Criteria:
  • Documented AF/VA in past 12 months
  • Cerebral Vascular Accident (CVA) or Transient Ischemic Attack (TIA) in past year
  • Has current implanted pulse generator, defibrillator, pacemaker, or resynchronization device
  • heart surgery within past 90 days
  • Myocardial Infarction within past 90 days
  • Patient is taking an anti-arrhythmic or anticoagulant
  • has concomitant condition that precludes safe participation in study (substance abuse, etc)
  • Enrollment in separate study that could confound results of this study

Trial Officials

Robert S Copeland-Halperin, MD

Principal Investigator

Northwell Health

Haisam Ismail, MD

Principal Investigator

Northwell Health

About Northwell Health

Northwell Health is a leading integrated health system based in New York, dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to improving patient outcomes and enhancing medical knowledge, Northwell Health conducts a diverse range of clinical studies across various therapeutic areas. The organization harnesses its extensive network of hospitals, outpatient facilities, and research institutes to facilitate cutting-edge research, ensuring access to advanced treatments for patients while fostering collaboration among healthcare professionals, researchers, and industry partners. By prioritizing patient-centric approaches and leveraging state-of-the-art technology, Northwell Health aims to drive significant advancements in medical science and public health.

Locations

New Hyde Park, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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