Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2021
Randomized comparison of oesophageal protection with a temperature control device: results of the IMPACT study.
Trial report 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, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 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
47 citing papers in PubMed, 2 syntheses or guidelines pooled it, 78 citations in OpenAlex.
- Esophageal injury, perforation, and fistula formation following atrial fibrillation ablation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024Pooled it
- Role of oesophageal cooling in the prevention of oesophageal injury in atrial fibrillation catheter ablation: a systematic review and meta-analysis of randomized controlled trials.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 · 2023Pooled it
- Effect of esophageal cooling on ablation lesion formation in the left atrium: Insights from Ablation Index data in the IMPACT trial and clinical outcomes.Journal of cardiovascular electrophysiology · 2022Trial
- Esophageal temperature management during cryoballoon ablation for atrial fibrillation.Journal of cardiovascular electrophysiology · 2022Trial
- Participant-reported chest pain and gastric esophageal reflux disease following protective esophageal cooling during radiofrequency ablation for atrial fibrillation - the EVERCOOL-AF study.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026Article
- [Catheter ablation-induced esophageal complications].Herzschrittmachertherapie & Elektrophysiologie · 2026Review
- Association between the sedation type and the risk of major oesophageal injury following increased intraoesophageal temperature during radiofrequency ablation for the treatment of atrial fibrillation.Journal of thoracic disease · 2026Article
- Two-stage surgery of atrioesophageal fistula after radiofrequency catheter ablation: case report and literature review.Journal of cardiothoracic surgery · 2025Review
- Active esophageal cooling reduces peri-esophageal and vagal nerve injury in radiofrequency-current pulmonary vein isolation.Heart rhythm O2 · 2025Article
- Reduced continuity index with proactive esophageal cooling compared to luminal temperature monitoring during radiofrequency ablation.Heart rhythm O2 · 2025Article
- Esophageal Protection Strategies for Ablation of Atrial Fibrillation: Comparative Results of Consecutive Endoscopic Evaluation.Arquivos brasileiros de cardiologia · 2025Article
- Case Report: Fatal atrioesophageal fistula following atrial fibrillation ablation-critical reflections on prevention.Frontiers in cardiovascular medicine · 2025Article
- Proactive esophageal cooling during radiofrequency cardiac ablation: data update including applications in very high-power short duration ablation.Expert review of medical devices · 2025Review
- From Fluttering Hearts to Restless Stomach: Navigating Atrial Fibrillation, Ablation and Gastroparesis.European journal of case reports in internal medicine · 2025Article
- Subarachnoid hemorrhage as the initial imaging finding of atrial-esophageal Fistula: a case report highlighting diagnostic challenges.Frontiers in cardiovascular medicine · 2025Article
- Anatomical characteristics of mitral isthmus and its spatial relationship with the esophagus in patients undergoing atrial fibrillation ablation using CT angiography.Frontiers in cardiovascular medicine · 2025Article
- 2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation.Journal of arrhythmia · 2024Article
- 2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024Article
- Hybrid convergent procedure with proactive oesophageal cooling for the treatment of long-standing persistent atrial fibrillation: a case series.European heart journal. Case reports · 2024Article
- Mechanisms of action behind the protective effects of proactive esophageal cooling during radiofrequency catheter ablation in the left atrium.Heart rhythm O2 · 2024Review
Corrections and comments
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Authors and funding
15 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThermal injury to the oesophagus is an important cause of life-threatening complication after ablation for atrial fibrillation (AF). Thermal protection of the oesophageal lumen by infusing cold liquid reduces thermal injury to a limited extent. We tested the ability of a more powerful method of oesophageal temperature control to reduce the incidence of thermal injury. METHODS AND
resultsA single-centre, prospective, double-blinded randomized trial was used to investigate the ability of the ensoETM device to protect the oesophagus from thermal injury. This device was compared in a 1:1 randomization with a control group of standard practice utilizing a single-point temperature probe. In the protected group, the device maintained the luminal temperature at 4°C during radiofrequency (RF) ablation for AF under general anaesthesia. Endoscopic examination was performed at 7 days post-ablation and oesophageal injury was scored. The patient and the endoscopist were blinded to the randomization. We recruited 188 patients, of whom 120 underwent endoscopy. Thermal injury to the mucosa was significantly more common in the control group than in those receiving oesophageal protection (12/60 vs. 2/60; P = 0.008), with a trend toward reduction in gastroparesis (6/60 vs. 2/60, P = 0.27). There was no difference between groups in the duration of RF or in the force applied (P value range= 0.2-0.9). Procedure duration and fluoroscopy duration were similar (P = 0.97, P = 0.91, respectively).
conclusionThermal protection of the oesophagus significantly reduces ablation-related thermal injury compared with standard care. This method of oesophageal protection is safe and does not compromise the efficacy or efficiency of the ablation procedure.
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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.