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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Incidence of device detected atrial fibrillation (AF) [Срок оценки: at 18 months after start of BTK inhibitor]
• Long term Incidence of device detected AF [Срок оценки: up to 60 months after device implantation]

Вторичные конечные точки (4)

• Incidence of device detected ventricular arrhythmia (VA) [Срок оценки: at 18 months after start of BTK inhibitor]
• BTK dose reduction or discontinuation due to device detected arrhythmia, assessed by chart review. [Срок оценки: up to 60 months after device implantation]
• Initiation of anticoagulation for AF detected by device monitoring, assessed by chart review [Срок оценки: up to 60 months after device implantation]
• Long term incidence of device detected ventricular arrhythmia (VA) [Срок оценки: up to 60 months after device implantation]

Критерии участия

Критерии включения

• >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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Northwell (Northshore University/Long Island Jewish Hospitals) — New Hyde Park

Публикации

• 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. PMID 30573111
• Baptiste 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. PMID 31168393
• Guha 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. PMID 30072003
• Lampson 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. PMID 28223277
• Byrd 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. PMID 30842083
• Tam 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 PMID 32731259
• Janssen 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).

Идентификаторы

NCT: NCT05643235 · IRB 22-0256 · ERP-2021-12882

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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