RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will enroll patients initiating Bruton Tyrosine Kinase (BTK) inhibitors without history of documented arrhythmia while on therapy using the Medtronic LINQ-2 insertable cardiac monitor (ILR). The incidence of new onset atrial fibrillation (AF) and other arrhythmia will be determined. Actions taken in response to device detected arrhythmia will be recorded.

Official Title

Implanted Loop Recorders (ILR) for the Detection and Management of Arrhythmia in Patients Treated With Bruton Tyrosine Kinase (BTK) Inhibitors

Quick Facts

Study Start:2023-01-01
Study Completion:2030-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05643235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \>18yo
  2. * Willing to sign and date consent form,
  3. * Willing to be remotely monitored
  4. * Initiating BTK inhibitor for approved condition (i.e. CLL, Waldenstrom's, etc)
  5. * Willing to have Medtronic cardiac monitor inserted to allow at minimum 24 hours continuous monitoring prior to initiating BTK inhibitor
  1. * Documented AF/VA in past 12 months
  2. * Cerebral Vascular Accident (CVA) or Transient Ischemic Attack (TIA) in past year
  3. * Has current implanted pulse generator, defibrillator, pacemaker, or resynchronization device
  4. * heart surgery within past 90 days
  5. * Myocardial Infarction within past 90 days
  6. * Patient is taking an anti-arrhythmic or anticoagulant
  7. * has concomitant condition that precludes safe participation in study (substance abuse, etc)
  8. * Enrollment in separate study that could confound results of this study

Contacts and Locations

Study Contact

Efstathia Mihelis
CONTACT
212-434-6614
emihelis@northwell.edu
Robert S Copeland-Halperin, MD
CONTACT
718-470-7330

Principal Investigator

Robert S Copeland-Halperin, MD
PRINCIPAL_INVESTIGATOR
Northwell Health
Haisam Ismail, MD
PRINCIPAL_INVESTIGATOR
Northwell Health

Study Locations (Sites)

Northwell (Northshore University/Long Island Jewish Hospitals)
New Hyde Park, New York, 11040
United States

Collaborators and Investigators

Sponsor: Northwell Health

  • Robert S Copeland-Halperin, MD, PRINCIPAL_INVESTIGATOR, Northwell Health
  • Haisam Ismail, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01
Study Completion Date2030-12-01

Study Record Updates

Study Start Date2023-01-01
Study Completion Date2030-12-01

Terms related to this study

Keywords Provided by Researchers

  • 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)

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • Supraventricular Arrhythmia
  • Ventricular Arrhythmias and Cardiac Arrest
  • Chronic Lymphocytic Leukemia
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma