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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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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