Trial reportEuropean heart journal2019
Safety and efficiency of a common and simplified protocol for pacemaker and defibrillator surveillance based on remote monitoring only: a long-term randomized trial (RM-ALONE).
Trial report in European heart journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
50 citing papers in PubMed, 2 syntheses or guidelines pooled it, 113 citations in OpenAlex.
- Investigating the Cost-Effectiveness of Telemonitoring Patients With Cardiac Implantable Electronic Devices: Systematic Review.Journal of medical Internet research · 2024Pooled it
- Long-Term Remote vs. Conventional Monitoring of Pacemakers: Systematic Review and Meta-Analysis of Randomized Controlled Trials.Current cardiology reports · 2023Pooled it
- Informational letters or postcards to initiate remote monitoring among veterans with pacemakers and implantable cardioverter-defibrillators: A randomized, controlled trial.Pacing and clinical electrophysiology : PACE · 2024Trial
- Informational Postcards Increase Engagement with Remote Monitoring Among Veterans with Pacemakers and Implantable Cardioverter-Defibrillators: a Stepped-Wedge Randomized Controlled Trial.Journal of general internal medicine · 2024Trial
- Referral decisions based on a pre-hospital HEART score in suspected non-ST-elevation acute coronary syndrome: final results of the FamouS Triage study.European heart journal. Acute cardiovascular care · 2022Trial
- Long-term cost-utility analysis of remote monitoring of older patients with pacemakers: the PONIENTE study.BMC geriatrics · 2020Trial
- Trial
- Trial
- Expert Consensus Statement: Committee on Implantable Devices and Committee on Social Issues, Japanese Heart Rhythm Society (JHRS) Statement on Remote Monitoring of Cardiac Implantable Electronic Devices.Journal of arrhythmia · 2026Article
- Review
- Remote monitoring and outcomes in heart failure: 5-year study.Journal of cardiovascular medicine (Hagerstown, Md.) · 2026Article
- Utilization and implementation of remote monitoring of cardiac implantable electronic devices in Australia and New Zealand: Adoption, workload, and integration challenges.Heart rhythm O2 · 2026Article
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- Preferences of Patients and Cardiologists Regarding Pacemaker Characteristics in Spain: A Discrete Choice Experiment.Patient preference and adherence · 2026Article
- Comparison Between In-Office Versus Remote Follow-Up Costs in Patients with Pacemakers and Reimbursed Transportation in a Portuguese District Hospital.Healthcare (Basel, Switzerland) · 2025Article
- Global Research Trends and Hotspots in Cardiac Devices: A Bibliometric and Visual Analysis.Healthcare (Basel, Switzerland) · 2025Review
- Outcomes associated with remote monitoring without in-person evaluations for patients with cardiovascular implantable electronic devices.Heart rhythm O2 · 2025Article
- From Clinic to Cloud: Efficacy of AI-Assisted Remote Monitoring of Patients With Implantable Cardiac Devices.Pacing and clinical electrophysiology : PACE · 2025Review
- EHRA perspective on the digital data revolution in arrhythmia management: insights from the association's annual summit.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025Review
- Article
Corrections and comments
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Authors and funding
10 authors at 9 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThis trial aimed to evaluate the safety and efficiency of a common and simplified protocol for the surveillance of cardiac implantable electronic devices based on remote monitoring (RM) in patients with pacemakers (PMs) and implantable cardiac defibrillators (ICDs) for at least 24 months. METHODS AND
resultsThe RM-ALONE is a multicentre prospective trial that randomly assigned 445 patients in two groups, both followed by RM: the home monitoring-only (HMo) based on RM + remote interrogations (RIs) every 6 months and the HM + IO that adds in-office evaluations every 6 months to RM. Four hundred and forty-five patients were enrolled in the study, 294 PMs and 151 ICDs recipients. In the HMo group, 20% of patients experienced ≥1 major adverse cardiac event (MACE) vs. 19.5% in HM + IO group (P = 0.006 for non-inferiority). The proportion of patients with a PM/ICD who experienced ≥1 MACE was 15.2/29.3% in HMo group and 16.1/26.3% in HM + IO group (hazard ratio 0.95/1.15, 95% confidence interval 0.53-1.70/0.62-2.10). There were 789 in-office evaluations (136 in the HMo and 653 in the HM + IO; P < 0.001). There was a 79.2% reduction of in-office evaluations with no significant differences in unscheduled visits between groups: 122 (54.5%) in HMo and 101 (45.3%) in HM + IO; P = 0.15. The time a physician/nurse spent per patient/follow-up was significantly reduced in the HMo group: 4/5 min (0-30)/(1-30) vs. 10/10 min (0-40)/(1-40) in HM + IO (P < 0.0001).
conclusionThe RM-ALONE protocol common for ICD and PM surveillance, consisting of RM + RI every 6 months has proven safe and efficient in reducing hospital visits and staff workload.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.