Observational studyEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2023
New insertable cardiac monitors show high diagnostic yield and good safety profile in real-world clinical practice: results from the international prospective observational SMART Registry.
Observational study in 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, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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.
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Who cites it
11 citing papers in PubMed, 11 citations in OpenAlex.
- Implantable Cardiac Monitoring for Atrial Fibrillation Detection in Patients with Stroke: A Systematic Review and Meta-Analysis.NeuroSci · 2026Review
- Safety, performance, and remote programming utilization of an insertable cardiac monitor: The LUX-Dx PERFORM study.Heart rhythm O2 · 2026Article
- Diagnostic and therapeutic impact of implantable cardiac monitors across different clinical indications: a real-world cohort.European heart journal open · 2026Article
- Long-term, ambulatory 12-lead ECG from a single non-standard lead using perceptual reconstruction.medRxiv : the preprint server for health sciences · 2025Article
- Seeing Is Believing: Use of Insertable Cardiac Monitors to Detect Arrhythmias in Heart Failure.JACC. Heart failure · 2025Article
- The Diagnostic Yield of Implantable Loop Recorders Stratified by Indication: A "Real-World" Single-Center Experience.Journal of clinical medicine · 2025Article
- Atrial fibrillation in Retinal Artery Occlusions.Cardiology and cardiovascular medicine · 2025Article
- "Real-world" performance of the Confirm Rx™ SharpSense AF detection algorithm: UK Confirm Rx study.Journal of arrhythmia · 2024Article
- Review
- Feasibility, safety, and comfort of the '2BB' (2 cm below the bra) position of insertable cardiac monitors in women: the IN-WOMEN-ICM pilot study.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 · 2024Article
- Definitive aetiology of unexplained syncope after cardiovascular autonomic tests in a tertiary syncope unit.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 · 2023Article
Corrections and comments
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Authors and funding
15 authors at 11 institutions in 6 countries.
Funding
Abstract
aimsInsertable cardiac monitors (ICMs) are indicated for long-term monitoring of unexplained syncope or palpitations, and for detection of bradycardia, ventricular tachycardia, and/or atrial fibrillation (AF). The aim of our study was to evaluate the safety and clinical value associated with a new generation ICM (Confirm Rx™, Abbott, Illinois, USA), featuring a new remote monitoring system based on smartphone patient applications. METHODS AND
resultsThe SMART Registry is an international prospective observational study. The main endpoints were ICM safety (incidence of serious adverse device and procedure-related events (SADEs) at 1 month), ICM clinical value (incidence of device-detected true arrhythmias and of clinical diagnoses and interventions), and patient-reported experience measurements (PREMs). A total of 1400 subjects were enrolled. ICM indications included syncope (49.1%), AF (18.8%), unexplained palpitations (13.6%), risk of ventricular arrhythmia (6.6%), and cryptogenic stroke (6.0%). Freedom from SADEs at 1 month was 99.4% (95% Confidence Interval: 98.8-99.7%). In the 6-month monitoring period, the ICM detected true cardiac arrhythmias in 45.7% of patients and led to clinical interventions in a relevant proportion of patients; in particular, a pacemaker implant was performed after bradycardia detection in 8.9% of subjects who received an ICM for syncope and oral anticoagulation therapy was indicated after AF detection in 15.7% of subjects with cryptogenic stroke. PREMs showed that 78.2% of subjects were satisfied with the remote monitoring patient app.
conclusionThe evaluated ICM is associated with an excellent safety profile and high diagnostic yield. Patients reported positive experiences associated with the use of their smartphone for the device remote monitoring.
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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.