Randomized Pragmatic Trial of Pacemaker Versus Implantable Cardiac Monitor in Syncope and Bifascicular Block
Open accessAbstract
Objectives In this study, the authors tested whether a strategy of empiric permanent pacing reduces major composite events more effectively than acting on the results of an implantable cardiac monitor (ICM). Background Syncope may be caused by intermittent complete heart block in patients with bifascicular heart block, but competing diagnoses coexist. Whether empiric permanent pacing or acting on investigative results provides best care is unknown. Methods This was a multinational, randomized, pragmatic clinical trial of patients ≥50 years of age with bifascicular block, preserved left ventricular function, and ≥1 syncope in the preceding year. The primary composite outcome measure comprised cardiovascular death, syncope, bradycardia resulting in pacemaker insertion, and device complications. Results There were 57 and 58 subjects randomized to receive a pacemaker or ICM. A total of 41 patients had left bundle branch block and 74 had right bundle branch block and a left fascicular block. Patients were followed for a median 33 months. There were fewer composite primary outcomes in patients randomized to pacemaker compared with ICM, respectively (20 [35%] vs 44 [76%]; chi square P Conclusions Empiric permanent pacing compared with ICM reduced major adverse events but not syncope in older patients with bifascicular block and recent syncope. There remains a substantial likelihood of syncope recurrence in patients who receive a permanent pacemaker likely caused by vasodepressor syn…
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Only two studies reported cardiovascular mortality and device complications, yielding sparse evidence.
“Only two studies reported cardiovascular mortality and device complications, yielding sparse evidence [7], [8].”
From Empiric pacing in unexplained syncope and bifascicular block: A systematic review and meta-analysis (2026) · cites this paper as [8]
SPRITELY demonstrated substantial crossover from the implantable cardiac monitor arm to pacemaker due to disease progress, and all patients in the non-intervention arm (100%) ultimately received pacemakers.
“Regardless, SPRITELY has demonstrated that there was substantial crossover from the ICM arm to pacemaker due to disease progress, and all patients in the non-intervention arm (100%) ultimately received pacemakers [8].”
From Empiric pacing in unexplained syncope and bifascicular block: A systematic review and meta-analysis (2026) · cites this paper as [8]
Six primary studies were analyzed in the final meta-analysis.
“Six primary studies were analyzed in the final meta-analysis (Table 1) [6], [7], [8], [16], [18], [19].”
From Empiric pacing in unexplained syncope and bifascicular block: A systematic review and meta-analysis (2026) · cites this paper as [8]
The SPRITELY trial demonstrated that patients with bifascicular block were also prone to syncope due to a vasovagal response.
“The SPRITELY trial further refined this understanding by demonstrating that while bradycardia necessitating pacemaker implantation remained a concern, patients with BFB were also prone to syncope due to a vasovagal response [8].”
From Empiric pacing in unexplained syncope and bifascicular block: A systematic review and meta-analysis (2026) · cites this paper as [8]
Cites
Discrete sequential boundaries for clinical trials
GORDON LAN, K. K., & DEMETS, D. L. (1983) · Biometrika · doi:10.1093/biomet/70.3.659 · Cited by 2,310 · see citing works
2018 ESC Guidelines for the diagnosis and management of syncope
Brignole, M., Moya, A., de Lange, F. J., Deharo, J.-C., Elliott, P. M., Fanciulli, A., Fedorowski, A., Furlan, R., Kenny, R. A., Martín, A., et al. (2018) · European Heart Journal · doi:10.1093/eurheartj/ehy037 · Cited by 1,951 · see citing works
Self-citationA pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers
Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., Tunis, S., Bergel, E., Harvey, I., Magid, D. J., et al. (2009) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2008.12.011 · Cited by 1,389 · see citing works
2018 ESC Guidelines for the diagnosis and management of syncope
Brignole, M., Moya‐Mitjans, À., de Lange, F. J., Deharo, J., Elliot, P. M., Fanciulli, A., Fedorowski, A., Furlan, R., Kenny, R. A., Martiın, A., et al. (2018) · Kardiologia Polska · doi:10.5603/kp.2018.0161 · Cited by 474 · see citing works
Self-citationA pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers
Thorpe, K. E., Zwarenstein, M., Oxman, A., Treweek, S. P., Furberg, C. D., Altman, D. G., Tunis, S., Bergel, E. F., Harvey, I. M., Magid, D. J., et al. (2009) · Canadian Medical Association Journal · doi:10.1503/cmaj.090523 · Cited by 422 · see citing works
Shen, W.-K., Sheldon, R. S., Benditt, D. G., Cohen, M. I., Forman, D. E., Goldberger, Z. D., Grubb, B. P., Hamdan, M. H., Krahn, A. D., Link, M. S., et al. (2017) · Circulation · doi:10.1161/cir.0000000000000498 · Cited by 408 · see citing works
Self-citationIndications for the use of diagnostic implantable and external ECG loop recorders
Task Force members, Brignole, M., Vardas, P., Hoffman, E., Huikuri, H., Moya, A., Ricci, R., Sulke, N., Wieling, W., EHRA Scientific Documents Committee, et al. (2009) · Europace · doi:10.1093/europace/eup097 · Cited by 362 · see citing works
Self-citationMechanism of syncope in patients with bundle branch block and negative electrophysiological test
Brignole, M., Menozzi, C., Moya, A., Garcia-Civera, R., Mont, L., Alvarez, M., Errazquin, F., Beiras, J., Bottoni, N., Donateo, P., et al. (2001) · Circulation · doi:10.1161/hc4201.097837 · Cited by 328 · see citing works
Self-citationDiagnostic criteria for vasovagal syncope based on a quantitative history
Sheldon, R., Rose, S., Connolly, S., Ritchie, D., Koshman, M.-L., & Frenneaux, M. (2006) · European Heart Journal · doi:10.1093/eurheartj/ehi584 · Cited by 252 · see citing works
Self-citationShen, W.-K., Sheldon, R. S., Benditt, D. G., Cohen, M. I., Forman, D. E., Goldberger, Z. D., Grubb, B. P., Hamdan, M. H., Krahn, A. D., Link, M. S., et al. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2017.03.002 · Cited by 155 · see citing works
Self-citationRelation of clinical presentation of syncope to the age of patients
Del Rosso, A., Alboni, P., Brignole, M., Menozzi, C., & Raviele, A. (2005) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2005.07.047 · Cited by 138 · see citing works
Self-citationDual-Chamber Pacing With Closed Loop Stimulation in Recurrent Reflex Vasovagal Syncope
Barón‐Esquivias, G., Morillo, C. A., Moya‐Mitjans, À., Martínez-Alday, J. D., Ruiz‐Granell, R., Lacunza, J., García–Civera, R., Gutiérrez‐Carretero, E., & Romero-Garrido, R. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2017.08.026 · Cited by 131 · see citing works
Self-citationDiagnosis, management, and outcomes of patients with syncope and bundle branch block
Moya, A., Garcia-Civera, R., Croci, F., Menozzi, C., Brugada, J., Ammirati, F., Del Rosso, A., Bellver-Navarro, A., Garcia-Sacristan, J., Bortnik, M., et al. (2011) · European Heart Journal · doi:10.1093/eurheartj/ehr071 · Cited by 124 · see citing works
SOLANO, A. (2004) · European Heart Journal · doi:10.1016/j.ehj.2004.05.013 · Cited by 122 · see citing works
Brignole, M., Moya‐Mitjans, À., Menozzi, C., García–Civera, R., & Sutton, R. (2005) · EP Europace · doi:10.1016/j.eupc.2004.11.001 · Cited by 106 · see citing works
Self-citationStatistical Controversies in Reporting of Clinical Trials
Pocock, S., McMurray, J. J. V., & Collier, T. J. (2015) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2015.10.023 · Cited by 95 · see citing works
Santini, M., Castro, A., Giada, F., Ricci, R., Inama, G., Gaggioli, G., Calò, L., Orazi, S., Viscusi, M., Chiodi, L., et al. (2013) · Circulation: Arrhythmia and Electrophysiology · doi:10.1161/circep.112.975102 · Cited by 84 · see citing works
Electrophysiologic evaluation of syncope in patients with bifascicular block
Ezri, M. D., Lerman, B. B., Marchlinski, F. E., Buxton, A. E., & Josephson, M. E. (1983) · American Heart Journal · doi:10.1016/0002-8703(83)90089-3 · Cited by 81 · see citing works
KALSCHEUR, M. M., DONATEO, P., WENZKE, K. E., ASTE, M., ODDONE, D., SOLANO, A., MAGGI, R., CROCI, F., PAGE, R. L., BRIGNOLE, M., et al. (2016) · Pacing and Clinical Electrophysiology · doi:10.1111/pace.12946 · Cited by 32 · see citing works
Self-citationNuevos predictores de evolución a bloqueo auriculoventricular en pacientes con bloqueo bifascicular
Martí‐Almor, J., Cladellas, M., Bazán, V., Delclós, J., Altaba, C., Guijo, M. A., Vila, J., Mojal, S., & Bruguera, J. (2010) · Revista Española de Cardiología · doi:10.1016/s0300-8932(10)70060-9 · Cited by 31 · see citing works
Martí‐Almor, J., Cladellas, M., Bazán, V., Delclós, J., Altaba, C., Guijo, M. A., Vila, J., Mojal, S., & Bruguera, J. (2010) · Revista Española de Cardiología (English Edition) · doi:10.1016/s1885-5857(10)70088-8 · Cited by 23 · see citing works
Sheldon, R. S., Lei, L. Y., Solbiati, M., Chew, D. S., Raj, S. R., Costantino, G., Morillo, C. A., & Sandhu, R. K. (2021) · Heart Rhythm · doi:10.1016/j.hrthm.2021.04.010 · Cited by 21 · see citing works
Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
Arrhythmic syncope: From diagnosis to management
Pascual, J. F., Jordán, P., Silva, J. R., & Rivas‐Gándara, N. (2023) · World Journal of Cardiology · doi:10.4330/wjc.v15.i4.119 · Cited by 28 · see citing works
Diederichsen, S. Z., Xing, L. Y., Frodi, D. M., Kongebro, E. K., Haugan, K., Graff, C., Højberg, S., Krieger, D. W., Brandes, A., Køber, L., et al. (2023) · JAMA Cardiology · doi:10.1001/jamacardio.2022.5526 · Cited by 28 · see citing works
Pathophysiology of syncope: current concepts and their development
Benditt, D. G., Fedorowski, A., Sutton, R., & van Dijk, J. G. (2024) · Physiological Reviews · doi:10.1152/physrev.00007.2024 · Cited by 23 · see citing works
Palmisano, P., Guerra, F., Aspromonte, V., Dell’Era, G., Pellegrino, P. L., Laffi, M., Uran, C., De Bonis, S., Accogli, M., Dello Russo, A., et al. (2022) · Heart Rhythm · doi:10.1016/j.hrthm.2022.05.023 · Cited by 11 · see citing works
Canadian Cardiovascular Society 2023 Guidelines on the Fitness to Drive
Guerra, P. G., Simpson, C. S., Spall, H. G. C. V., Asgar, A., Billia, F., Cadrin‐Tourigny, J., Chakrabarti, S., Cheung, C. C., Dore, A., Fordyce, C. B., et al. (2023) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2023.09.033 · Cited by 11 · see citing works
Self-citationKatapadi, A., Chelikam, N., Garg, J., Gopinathannair, R., Park, P. J., Darden, D. J., Pothineni, N. V. K., Atkins, D., Kabra, R., Bommana, S., et al. (2025) · Heart Rhythm · doi:10.1016/j.hrthm.2025.01.011 · Cited by 8 · see citing works
A Cost-Utility Analysis of the Syncope: Pacing or Recording in The Later Years (SPRITELY) Trial
Hofmeister, M., Sheldon, R. S., Spackman, E., Raj, S. R., Talajic, M. R., Becker, G., Essebag, V., Ritchie, D., Morillo, C. A., Krahn, A. D., et al. (2022) · CJC Open · doi:10.1016/j.cjco.2022.03.009 · Cited by 7 · see citing works
Self-citationRisk Stratification in Left Bundle Branch Block After Transcatheter Aortic Valve Implantation
Badertscher, P., Serban, T., Massoullié, G., Eschalier, R., Rivard, L., Portelance, D., Waksman, R., Pavlicek, V., Pascale, P., Pagnoni, M., et al. (2025) · JACC. Clinical electrophysiology · doi:10.1016/j.jacep.2025.09.010 · Cited by 6 · see citing works
Andrade, J. G., Joza, J. E., Chew, D. S., Paredes, F. A., Bennett, M. T., Essebag, V., Greiss, I., Hawkins, N. M., Khoo, C., Kulyk, K., et al. (2026) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2025.08.363 · Cited by 6 · see citing works
Self-citationNeira, V., Enriquez, A. A., Sheldon, R. S., Hanson, M. G., Maxey, C., & Baranchuk, A. M. (2022) · Heart Rhythm · doi:10.1016/j.hrthm.2022.09.018 · Cited by 6 · see citing works
Self-citationSyncope: Advances in Diagnosis and Treatment 2024
Sutton, R., Kenny, R. A., & Benditt, D. G. (2024) · Journal of Cardiovascular Electrophysiology · doi:10.1111/jce.16546 · Cited by 5 · see citing works
Zangiabadian, M., Soltani, K., Gholinejad, Y., Yahya, R., Bastami, S., Akbarzadeh, M. A., Ardestani, M. S., & Aletaha, A. (2024) · Clinical Cardiology · doi:10.1002/clc.24221 · Cited by 5 · see citing works
Outcomes of Primary vs. Delayed Strategy of Implanting a Cardiac Monitor for Unexplained Syncope
Yasa, E., Intzilakis, T., Ricci, F., Melander, O., Hamrefors, V., Sutton, R., & Fedorowski, A. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11071819 · Cited by 5 · see citing works
Tonegawa‐Kuji, R., Inoue, Y. Y., Nakai, M., Kanaoka, K., Sumita, Y., Miyazaki, Y., Wakamiya, A., Shimamoto, K., Ueda, N., Nakajima, K., et al. (2022) · CJC Open · doi:10.1016/j.cjco.2022.12.007 · Cited by 5 · see citing works
Pascual, J. F., Rivas‐Gándara, N., Ballesteros, M. M., Badia-Molins, C., Bach-Oller, M., Benito, B., Pérez‐Rodon, J., Santos‐Ortega, A., Roca‐Luque, I., Rodríguez-Silva, J., et al. (2022) · Revista Española de Cardiología (English Edition) · doi:10.1016/j.rec.2022.11.009 · Cited by 4 · see citing works
Pascual, J. F., Rivas‐Gándara, N., Ballesteros, M. M., Badia-Molins, C., Bach-Oller, M., Benito, B., Pérez‐Rodon, J., Santos‐Ortega, A., Roca‐Luque, I., Rodríguez-Silva, J., et al. (2023) · Revista Española de Cardiología · doi:10.1016/j.recesp.2022.11.010 · Cited by 4 · see citing works
Rivard, L., Nault, I., Krahn, A. D., Daneault, B., Roux, J.-F., Natarajan, M. K., Healey, J. S., Quadros, K., Sandhu, R. K., Kouz, R., et al. (2023) · CJC Open · doi:10.1016/j.cjco.2023.05.009 · Cited by 3 · see citing works
Self-citationChew, D. S., & Gillis, A. M. (2023) · Heart Rhythm · doi:10.1016/j.hrthm.2023.01.030 · Cited by 3 · see citing works
William, J., Nanayakkara, S., Chieng, D., Sugumar, H., Ling, L., Patel, H. C., Mariani, J. A., Prabhu, S., Kistler, P. M., & Voskoboinik, A. (2024) · Heart Rhythm · doi:10.1016/j.hrthm.2024.03.038 · Cited by 2 · see citing works
Fumagalli, C., Rafanelli, M., Brignole, M., Guarducci, C., Bettoni, N., Rivasi, G., Pieragnoli, P., Ricciardi, G., Checchi, L., Gambardella, M., et al. (2023) · International Journal of Cardiology · doi:10.1016/j.ijcard.2022.10.171 · Cited by 2 · see citing works
Self-citationSzaszkiewicz, J., Sheldon, R. S., Raj, S. R., & Rabajoli, A. (2025) · Clinical Autonomic Research · doi:10.1007/s10286-025-01138-4 · Cited by 2 · see citing works
Self-citationProgress in the pharmacological management of vasovagal syncope
Giambusso, V. G., Rafanelli, M., & Sheldon, R. S. (2025) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2025.2596875 · Cited by 1 · see citing works
Self-citationAdvances in syncope: Recent evidence and clinical implications
Ramponi, G., Paganuzzi, M. M., Solbiati, M., & Costantino, G. (2025) · European Journal of Internal Medicine · doi:10.1016/j.ejim.2025.106635 · Cited by 1 · see citing works
Empiric pacing in unexplained syncope and bifascicular block: A systematic review and meta-analysis
Fahim, M., Eldawud, D., Sharma, N., Al-Abdou, A., Alkhatib, A., Omar, M. A., Wang, R., Gorantla, A., Khouri, P., Jallad, A., et al. (2026) · IJC Heart & Vasculature · doi:10.1016/j.ijcha.2026.101894
Minority Report: Applications in Cardiology?
Kusumoto, F. M. (2022) · JACC. Clinical electrophysiology · doi:10.1016/j.jacep.2021.10.008
Badshah, M. B., Shaukat, M. H. S., Birlas, A., & Pham, S. (2023) · Cureus · doi:10.7759/cureus.33925
Síncope y bloqueo de rama: un estudio y varios mensajes para recordar
Pérez‐Castellano, N., Calvo, D., & Pérez‐Villacastín, J. (2023) · Revista Española de Cardiología · doi:10.1016/j.recesp.2023.01.016
Syncope and bundle branch block: a single study with several take-home messages
Pérez‐Castellano, N., Cuervo, D. C., & Pérez‐Villacastín, J. (2023) · Revista Española de Cardiología (English Edition) · doi:10.1016/j.rec.2023.01.014
Tilt testing or implantable cardiac monitoring in the diagnosis of unexplained syncope
Rabajoli, A., Chew, D. S., Szaszkiewicz, J., Raj, S. R., Cua, M., Morillo, C. A., & Sheldon, R. S. (2025) · Internal and Emergency Medicine · doi:10.1007/s11739-025-04128-6
Self-citationAlotaibi, R. M., & Alamir, H. I. A. (2026) · Case Reports in Cardiology · doi:10.1155/cric/9653777
Syncope and the heart: When to suspect and how to act?
Ruzieh, M., Hamdan, M. H., & Goldberger, Z. D. (2026) · Heart · doi:10.1136/heartjnl-2025-326964
Judgey, A., Angihan, J., Hamzeh, R., Raj, S. R., Morillo, C. A., & Sheldon, R. S. (2026) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2026.07.374
Self-citationAntonazzo, B., Sirignano, A., Salvini, M., Rossi, F. F., RONZONI, S., Dorizzi, A., Ellenbogen, K. A., Biondi‐Zoccai, G., & Calcagno, S. (2026) · Journal of Clinical Medicine · doi:10.3390/jcm15166303
- Authors
- Sheldon, R., Talajic, M., Tang, A., Becker, G., Essebag, V., Sultan, O., Baranchuk, A., Ritchie, D., Morillo, C., Krahn, A., Brignole, M., Manns, B., Maxey, C., & Raj, S. R.
- Affiliations
- University of Calgary (CA)
- Montreal Heart Institute (CA)
- Western University (CA)
- McGill University (CA)
- Regina General Hospital (CA)
- Queen's University (CA)
- University of British Columbia (CA)
- Presidio Ospedaliero (IT)
- Corresponding author
- Sheldon, Robert
- ORCID
- Venue
- JACC: Clinical Electrophysiology
- Publisher
- Elsevier BV
- Published
- 2022-02
- Volume
- 8
- Issue
- 2
- Pages
- 239-248
- ISSN
- 2405-500X (ISSN-L)
- OpenAlex
- W3217147487
- Cited by
- 32
- References
- 22
- Citations by year
- 2026: 5 · 2025: 6 · 2024: 4 · 2023: 9 · 2022: 8
- FWCI
- 3.55
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- JACC. Clinical electrophysiology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Canadian Institutes of Health Research (MOP 111094)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac pacing and defibrillation studies
- Health Sciences › Medicine › Surgery › Cardiovascular Syncope and Autonomic Disorders
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac electrophysiology and arrhythmias
- Keywords
- syncope, bifascicular block, permanent cardiac pacing, implantable cardiac monitors, left bundle branch block, right bundle branch block, bradycardia, cardiovascular mortality, device complications, older adults, vasodepressor syncope
- MeSH terms
- Aged, Arrhythmias, Cardiac, Bundle-Branch Block, Cardiac Pacing, Artificial, Humans, Pacemaker, Artificial, Syncope
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
