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

Primary Purpose

Atrial Fibrillation, Supraventricular Arrhythmia, Ventricular Arrhythmias and Cardiac Arrest

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northwell (Northshore University/Long Island Jewish Hospitals)Recruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients initiated on Bruton tyrosine kinase inhibitors, consenting to installment of ILR

Arm Description

Patients free of documented arrhythmia initiating treatment with a BTK inhibitor who consent to monitoring using the Medtronic LINQ-2 implanted cardiac monitoring device (ILR) prior to initiating BTK inhibitor therapy.

Outcomes

Primary Outcome Measures

Incidence of device detected atrial fibrillation (AF)

Incidence of AF lasting 6 or more minutes at 18 months: each arrhythmic episode detected by the patient's device will be reviewed to determine if it is 1) an actual AF episode, and 2) is at least 6 minutes in duration.

Long term Incidence of device detected AF

Incidence of AF lasting 6 or more minutes up to 60 months: each arrhythmic episode detected by the patient's device will be reviewed to determine if it is 1) an actual AF episode, and 2) is at least 6 minutes in duration.

Secondary Outcome Measures

Incidence of device detected ventricular arrhythmia (VA)

Incidence of VA is defined as follows: greater than or equal to 3 sequential wide complex beats arising from the ventricles, rate > 100 beats per minute at 18 months after start of BTK inhibitor therapy.

BTK dose reduction or discontinuation due to device detected arrhythmia, assessed by chart review.

Clinical actions including BTK dose reduction, interruption, discontinuation, or change in oncologic treatment by treating oncologist because of device detected arrhythmia.

Initiation of anticoagulation for AF detected by device monitoring, assessed by chart review

Prescription of an approved anticoagulant drug (apixaban, dabigatran, rivaroxaban, edoxaban, warfarin, aspirin) for prevention of stroke/systemic embolism based on AF detected by ILR

Long term incidence of device detected ventricular arrhythmia (VA)

Incidence of VA is defined as follows: greater than or equal to 3 sequential wide complex beats arising from the ventricles, rate > 100 beats per minute up to 60 months after device implant.

Full Information

NCT ID

NCT05643235

First Posted

November 22, 2022

Last Updated

December 1, 2022

Sponsor

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT05643235

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2022 (Actual)

Primary Completion Date

May 1, 2024 (Anticipated)

Study Completion Date

November 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

This single arm, prospective non-blinded study will enroll 50 patients initiating treatment with BTK inhibitors (ibrutinib, acalabrutinib, zanubrutinib or pirtobrutinib) without documented arrhythmia prior to starting BTK inhibitor therapy, without contraindications to an implanted loop recorder (ILR). They will be offered the option of monitoring arrhythmias using the Medtronic LINQ-2 insertable cardiac monitor (ILR). Monitoring data will be collected prospectively until the patient withdraws consent, the device is removed, or up to 60 months. Investigators hope to obtain information on arrhythmia incidence including AF, ventricular arrhythmia (VA), and actions taken in response to awareness of such episodes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

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)

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single arm, prospective study of implanted loop recorders (ILR) for the detection of arrhythmia in patients initiating treatment with BTK inhibitors.

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients initiated on Bruton tyrosine kinase inhibitors, consenting to installment of ILR

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)

Intervention Description

Patients initiating BTK inhibitors will be offered the option of monitoring using the Medtronic Insertable Cardiac Monitor (ILR). The device will be implanted by a certified and credentialed electrophysiologist to enable monitoring to begin at least 24 hours prior to the first administration of the BTK inhibitor. Monitoring data will be collected prospectively until the patient withdraws consent, the device is removed, or up to 60 months

Primary Outcome Measure Information:

Title

Incidence of device detected atrial fibrillation (AF)

Description

Time Frame

at 18 months after start of BTK inhibitor

Title

Long term Incidence of device detected AF

Description

Time Frame

up to 60 months after device implantation

Secondary Outcome Measure Information:

Title

Incidence of device detected ventricular arrhythmia (VA)

Description

Time Frame

at 18 months after start of BTK inhibitor

Title

BTK dose reduction or discontinuation due to device detected arrhythmia, assessed by chart review.

Description

Clinical actions including BTK dose reduction, interruption, discontinuation, or change in oncologic treatment by treating oncologist because of device detected arrhythmia.

Time Frame

up to 60 months after device implantation

Title

Initiation of anticoagulation for AF detected by device monitoring, assessed by chart review

Description

Prescription of an approved anticoagulant drug (apixaban, dabigatran, rivaroxaban, edoxaban, warfarin, aspirin) for prevention of stroke/systemic embolism based on AF detected by ILR

Time Frame

up to 60 months after device implantation

Title

Long term incidence of device detected ventricular arrhythmia (VA)

Description

Incidence of VA is defined as follows: greater than or equal to 3 sequential wide complex beats arising from the ventricles, rate > 100 beats per minute up to 60 months after device implant.

Time Frame

up to 60 months after device implantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Efstathia Mihelis

Phone

212-434-6614

emihelis@northwell.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Robert S Copeland-Halperin, MD

Phone

718-470-7330

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert S Copeland-Halperin, MD

Organizational Affiliation

Northwell Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Haisam Ismail, MD

Organizational Affiliation

Northwell Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwell (Northshore University/Long Island Jewish Hospitals)

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11040

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Efstathia A Mihelis

Phone

212-434-6614

emihelis@northwell.edu

First Name & Middle Initial & Last Name & Degree

Robert S. Copeland-Halperin, MD

Phone

718-470-7330

First Name & Middle Initial & Last Name & Degree

Michelle Jaeger, NP

First Name & Middle Initial & Last Name & Degree

Nandanee Karan

First Name & Middle Initial & Last Name & Degree

Joanna Rhodes, MD

First Name & Middle Initial & Last Name & Degree

Nicholas Beccarino, MD

First Name & Middle Initial & Last Name & Degree

Jason Ng, MD

First Name & Middle Initial & Last Name & Degree

Haisam Ismail, MD

First Name & Middle Initial & Last Name & Degree

Robert Copeland-Halperin, MD

First Name & Middle Initial & Last Name & Degree

Laurence Epstein, MD

12. IPD Sharing Statement

Plan to Share IPD

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

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