Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors
Recruiting · NCT05643235 · Interventional (participants receive a specific treatment) · Lead sponsor: Northwell Health
View the official record on ClinicalTrials.gov →Interventions studied
Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Northwell (Northshore University/Long Island Jewish Hospitals) - New Hyde Park, New York, United States