Atrial FibrillationNCT05643235
Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors
A study testing Medtronic LINQ-2 Insertable Cardiac Monitor (ILR) in people with Atrial Fibrillation and Supraventricular Arrhythmia, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Supraventricular Arrhythmia, Ventricular Arrhythmias and Cardiac Arrest
- What is being tested?
- Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Robert S Copeland-Halperin, MD contact
United States1 site, 1 recruiting
- Recruiting
Northwell (Northshore University/Long Island Jewish Hospitals)
New Hyde Park, New York, 11040
Efstathia A Mihelis, 212-434-6614, emihelis@northwell.edu
Robert S. Copeland-Halperin, MD, 718-470-7330
About this study
Official title: Implanted Loop Recorders (ILR) for the Detection and Management of Arrhythmia in Patients Treated With Bruton Tyrosine Kinase (BTK) Inhibitors
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Supraventricular Arrhythmia, Ventricular Arrhythmias and Cardiac Arrest, Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Being tested
- Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)
- 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)
- Medical subject headings
- Atrial Fibrillation, Heart Arrest, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Waldenstrom Macroglobulinemia, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Patients initiated on Bruton tyrosine kinase inhibitors, consenting to installment of ILR | Other | 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. Receives: Device: Medtronic LINQ-2 Insertable Cardiac Monitor (ILR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 18 months after start of BTK inhibitor
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.
Measured: up to 60 months after device implantation
Secondary outcomes (4)
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.
Measured: at 18 months after start of BTK inhibitor
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.
Measured: up to 60 months after device implantation
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
Measured: up to 60 months after device implantation
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.
Measured: up to 60 months after device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Jan 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Copeland-Halperin, MD FACC, Northwell Health
- Investigators
- Robert S Copeland-Halperin, MD, Principal investigator, Northwell HealthHaisam Ismail, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643235
- Sponsor's protocol ID
- IRB 22-0256
- Other IDs
- ERP-2021-12882
- Status last verified
- Sep 2025
- First submitted
- 22 Nov 2022
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ganatra S, Sharma A, Shah S, Chaudhry GM, Martin DT, Neilan TG, Mahmood SS, Barac A, Groarke JD, Hayek SS, Dani S, Venesy D, Patten R, Nohria A. Ibrutinib-Associated Atrial Fibrillation. JACC Clin Electrophysiol. 2018 Dec;4(12):1491-1500. doi: 10.1016/j.jacep.2018.06.004. Epub 2018 Aug 29.
PubMed 30573111Baptiste F, Cautela J, Ancedy Y, Resseguier N, Aurran T, Farnault L, Escudier M, Ammar C, Gaubert M, Dolladille C, Barraud J, Peyrol M, Cohen A, Paganelli F, Alexandre J, Ederhy S, Thuny F. High incidence of atrial fibrillation in patients treated with ibrutinib. Open Heart. 2019 May 8;6(1):e001049. doi: 10.1136/openhrt-2019-001049. eCollection 2019.
PubMed 31168393Guha A, Derbala MH, Zhao Q, Wiczer TE, Woyach JA, Byrd JC, Awan FT, Addison D. Ventricular Arrhythmias Following Ibrutinib Initiation for Lymphoid Malignancies. J Am Coll Cardiol. 2018 Aug 7;72(6):697-698. doi: 10.1016/j.jacc.2018.06.002. No abstract available.
PubMed 30072003Lampson BL, Yu L, Glynn RJ, Barrientos JC, Jacobsen ED, Banerji V, Jones JA, Walewska R, Savage KJ, Michaud GF, Moslehi JJ, Brown JR. Ventricular arrhythmias and sudden death in patients taking ibrutinib. Blood. 2017 May 4;129(18):2581-2584. doi: 10.1182/blood-2016-10-742437. Epub 2017 Feb 21. No abstract available.
PubMed 28223277Byrd JC, Hillmen P, O'Brien S, Barrientos JC, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Barr PM, Furman RR, Kipps TJ, Thornton P, Moreno C, Montillo M, Pagel JM, Burger JA, Woyach JA, Dai S, Vezan R, James DF, Brown JR. Long-term follow-up of the RESONATE phase 3 trial of ibrutinib vs ofatumumab. Blood. 2019 May 9;133(19):2031-2042. doi: 10.1182/blood-2018-08-870238. Epub 2019 Mar 6.
PubMed 30842083Tam CS, Opat S, D'Sa S, Jurczak W, Lee HP, Cull G, Owen RG, Marlton P, Wahlin BE, Sanz RG, McCarthy H, Mulligan S, Tedeschi A, Castillo JJ, Czyz J, Fernandez de Larrea C, Belada D, Libby E, Matous JV, Motta M, Siddiqi T, Tani M, Trneny M, Minnema MC, Buske C, Leblond V, Trotman J, Chan WY, Schneider J, Ro S, Cohen A, Huang J, Dimopoulos M. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenstrom macroglobulinemia: the ASPEN study. Blood. 2020 Oct 29;136(18):2038-2050. doi: 10.1182/blood.2020006844.
PubMed 32731259Janssen Biotech I. Imbruciva Prescribing Information. Janssen Biotech, Inc. 2020. Accessed December 21, 2021. https://www.imbruvica.com/files/prescribing-information.pdf
CALQUENCE PRESCRIBING INFORMATION (AstraZeneca Pharmaceuticals LP) (2019).
Ltd BU. Brukinsa Prescribing Information. 2021.
Munir T, Brown JR, O'Brien S, Barrientos JC, Barr PM, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Kipps TJ, Moreno C, Montillo M, Burger JA, Byrd JC, Hillmen P, Dai S, Szoke A, Dean JP, Woyach JA. Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Am J Hematol. 2019 Dec;94(12):1353-1363. doi: 10.1002/ajh.25638. Epub 2019 Oct 13.
PubMed 31512258Byrd JC, Hillmen P, Ghia P, Kater AP, Chanan-Khan A, Furman RR, O'Brien S, Yenerel MN, Illes A, Kay N, Garcia-Marco JA, Mato A, Pinilla-Ibarz J, Seymour JF, Lepretre S, Stilgenbauer S, Robak T, Rothbaum W, Izumi R, Hamdy A, Patel P, Higgins K, Sohoni S, Jurczak W. Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia: Results of the First Randomized Phase III Trial. J Clin Oncol. 2021 Nov 1;39(31):3441-3452. doi: 10.1200/JCO.21.01210. Epub 2021 Jul 26.
PubMed 34310172Medtronic. LINQ II LNQ22 ICM Clinician Manual. M974764A001D.
Sakhi R, Theuns DAMJ, Szili-Torok T, Yap SC. Insertable cardiac monitors: current indications and devices. Expert Rev Med Devices. 2019 Jan;16(1):45-55. doi: 10.1080/17434440.2018.1557046. Epub 2018 Dec 11.
PubMed 30522350Sakhi R, Huurman R, Theuns DAMJ, Schinkel AFL, Assaf A, Szili-Torok T, Roos-Hesselink JW, Michels M, Yap SC. Incremental Value of an Insertable Cardiac Monitor in Patients with Hypertrophic Cardiomyopathy with Low or Intermediate Risk for Sudden Cardiac Death. Cardiology. 2021;146(2):207-212. doi: 10.1159/000512656. Epub 2021 Jan 21.
PubMed 33477163Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Wachter R, Pouliot E, Ziegler PD; REVEAL AF Investigators. Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population: The REVEAL AF Study. JAMA Cardiol. 2017 Oct 1;2(10):1120-1127. doi: 10.1001/jamacardio.2017.3180.
PubMed 28842973
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implanted Loop Recorders (ILR) for the Detection and Management of Arrhythmia in Patients Treated With Bruton Tyrosine Kinase (BTK) Inhibitors
- ClinicalTrials.gov ID
- NCT05643235
- Acronym / sponsor ID
- IRB 22-0256
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, prospective study of implanted loop recorders (ILR) for the detection of arrhythmia in patients initiating treatment with BTK inhibitors.
| Arm | Type | Receives |
|---|---|---|
| Patients initiated on Bruton tyrosine kinase inhibitors, consenting to installment of ILR | Other | Device: Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)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 | Device | Patients initiated on Bruton tyrosine kinase inhibitors, consenting to installment of ILR |
Primary outcome
Incidence of device detected atrial fibrillation (AF)
Time frame: at 18 months after start of BTK inhibitor
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
Time frame: up to 60 months after device implantation
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.
4 secondary outcomes
Incidence of device detected ventricular arrhythmia (VA)
Time frame: at 18 months after start of BTK inhibitor
BTK dose reduction or discontinuation due to device detected arrhythmia, assessed by chart review.
Time frame: up to 60 months after device implantation
Initiation of anticoagulation for AF detected by device monitoring, assessed by chart review
Time frame: up to 60 months after device implantation
Long term incidence of device detected ventricular arrhythmia (VA)
Time frame: up to 60 months after device implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Background: PubMed 30573111Ganatra S, Sharma A, Shah S, Chaudhry GM, Martin DT, Neilan TG, Mahmood SS, Barac A, Groarke JD, Hayek SS, Dani S, Venesy D, Patten R, Nohria A. Ibrutinib-Associated Atrial Fibrillation. JACC Clin Electrophysiol. 2018 Dec;4(12):1491-1500. doi: 10.1016/j.jacep.2018.06.004. Epub 2018 Aug 29.
- Background: PubMed 31168393Baptiste F, Cautela J, Ancedy Y, Resseguier N, Aurran T, Farnault L, Escudier M, Ammar C, Gaubert M, Dolladille C, Barraud J, Peyrol M, Cohen A, Paganelli F, Alexandre J, Ederhy S, Thuny F. High incidence of atrial fibrillation in patients treated with ibrutinib. Open Heart. 2019 May 8;6(1):e001049. doi: 10.1136/openhrt-2019-001049. eCollection 2019.
- Background: PubMed 30072003Guha A, Derbala MH, Zhao Q, Wiczer TE, Woyach JA, Byrd JC, Awan FT, Addison D. Ventricular Arrhythmias Following Ibrutinib Initiation for Lymphoid Malignancies. J Am Coll Cardiol. 2018 Aug 7;72(6):697-698. doi: 10.1016/j.jacc.2018.06.002. No abstract available.
- Background: PubMed 28223277Lampson BL, Yu L, Glynn RJ, Barrientos JC, Jacobsen ED, Banerji V, Jones JA, Walewska R, Savage KJ, Michaud GF, Moslehi JJ, Brown JR. Ventricular arrhythmias and sudden death in patients taking ibrutinib. Blood. 2017 May 4;129(18):2581-2584. doi: 10.1182/blood-2016-10-742437. Epub 2017 Feb 21. No abstract available.
- Background: PubMed 30842083Byrd JC, Hillmen P, O'Brien S, Barrientos JC, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Barr PM, Furman RR, Kipps TJ, Thornton P, Moreno C, Montillo M, Pagel JM, Burger JA, Woyach JA, Dai S, Vezan R, James DF, Brown JR. Long-term follow-up of the RESONATE phase 3 trial of ibrutinib vs ofatumumab. Blood. 2019 May 9;133(19):2031-2042. doi: 10.1182/blood-2018-08-870238. Epub 2019 Mar 6.
- Background: PubMed 32731259Tam CS, Opat S, D'Sa S, Jurczak W, Lee HP, Cull G, Owen RG, Marlton P, Wahlin BE, Sanz RG, McCarthy H, Mulligan S, Tedeschi A, Castillo JJ, Czyz J, Fernandez de Larrea C, Belada D, Libby E, Matous JV, Motta M, Siddiqi T, Tani M, Trneny M, Minnema MC, Buske C, Leblond V, Trotman J, Chan WY, Schneider J, Ro S, Cohen A, Huang J, Dimopoulos M. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenstrom macroglobulinemia: the ASPEN study. Blood. 2020 Oct 29;136(18):2038-2050. doi: 10.1182/blood.2020006844.
- BackgroundJanssen Biotech I. Imbruciva Prescribing Information. Janssen Biotech, Inc. 2020. Accessed December 21, 2021. https://www.imbruvica.com/files/prescribing-information.pdf
- BackgroundCALQUENCE PRESCRIBING INFORMATION (AstraZeneca Pharmaceuticals LP) (2019).
- BackgroundLtd BU. Brukinsa Prescribing Information. 2021.
- Background: PubMed 31512258Munir T, Brown JR, O'Brien S, Barrientos JC, Barr PM, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Kipps TJ, Moreno C, Montillo M, Burger JA, Byrd JC, Hillmen P, Dai S, Szoke A, Dean JP, Woyach JA. Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Am J Hematol. 2019 Dec;94(12):1353-1363. doi: 10.1002/ajh.25638. Epub 2019 Oct 13.
- Background: PubMed 34310172Byrd JC, Hillmen P, Ghia P, Kater AP, Chanan-Khan A, Furman RR, O'Brien S, Yenerel MN, Illes A, Kay N, Garcia-Marco JA, Mato A, Pinilla-Ibarz J, Seymour JF, Lepretre S, Stilgenbauer S, Robak T, Rothbaum W, Izumi R, Hamdy A, Patel P, Higgins K, Sohoni S, Jurczak W. Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia: Results of the First Randomized Phase III Trial. J Clin Oncol. 2021 Nov 1;39(31):3441-3452. doi: 10.1200/JCO.21.01210. Epub 2021 Jul 26.
- BackgroundMedtronic. LINQ II LNQ22 ICM Clinician Manual. M974764A001D.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert S Copeland-Halperin, MD contact
Robert S Copeland-Halperin, MD principal investigator
Northwell Health
Haisam Ismail, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic LINQ-2 Insertable Cardiac Monitor (ILR) in people with Atrial Fibrillation and Supraventricular Arrhythmia, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Efstathia Mihelis (212-434-6614, emihelis@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of device detected atrial fibrillation (AF) (time frame: at 18 months after start of BTK inhibitor). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05643235, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.