Evidence map›Paper›PMID 27956248›Full record

Trial reportHeart rhythm2017

Individualized cryoballoon energy pulmonary vein isolation guided by real-time pulmonary vein recordings, the randomized ICE-T trial.

K R Julian Chun, Marie Stich, Alexander Fürnkranz, Stefano Bordignon, Laura Perrotta, Daniela Dugo, Fabrizio Bologna, Boris Schmidt

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Heart rhythm, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05939076 (First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation - a Randomized Study Comparing Early Trigger Isolation Using the Cryoballoon Versus Antiarrhythmic Medication), which is not on this map. Cited by 65 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 2 pooled it
12.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT05939076 phase3not yet recruitingnot on this mapstarted 2023, after this paper: background citation

First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation - a Randomized Study Comparing Early Trigger Isolation Using the Cryoballoon Versus Antiarrhythmic Medication

TypeinterventionalSponsorRegion Örebro CountyRan2023 to 2028Enrolled220ConditionsAtrial Fibrillation, PersistentArmsPulmonary vein isolation, dronedarone - Multaq™ OR flecainide - Tambocor™ OR propafenone - Rytmonorm™ OR sotalol - Sotacor™
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 2 syntheses or guidelines pooled it, 154 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Impact of cryoballoon application abortion due to phrenic nerve injury on reconnection rates: a YETI subgroup analysis.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
    Trial
  4. Individualized or fixed approach to pulmonary vein isolation utilizing the fourth-generation cryoballoon in patients with paroxysmal atrial fibrillation: the randomized INDI-FREEZE trial.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 · 2022
    Trial
  5. Pulmonary vein isolation using second-generation single-shot devices: not all the same?Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2021
    Trial
  6. Trial
  7. Trial
  8. Efficacy, safety, and somatosensory comparison of pulsed-field ablation and thermal ablation: outcomes from a 2-year follow-up.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
    Article
  9. Article
  10. Brazilian Atrial Fibrillation Guidelines - 2025.Arquivos brasileiros de cardiologia · 2025
    Article
  11. Article
  12. Temperature-guided high and very high-power short duration ablation for atrial fibrillation treatment: the peQasus multicentre 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 · 2025
    Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. In vivo safety and pulmonary vein isolation performance of a new cryoballoon for the treatment of atrial fibrillation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
    Article
  18. Article
  19. Initial real-world data on catheter ablation in patients with persistent atrial fibrillation using the novel lattice-tip focal pulsed-field ablation catheter.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 · 2024
    Article
  20. Regional variations in patient selection and procedural characteristics for cryoballoon ablation of atrial fibrillation in the cryo global registry.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
    Article

5 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

K R Julian ChunCCB - Cardioangiologisches Centrum Bethanien, Medizinische Klinik 3, Markuskrankenhaus, Frankfurt Am Main, Germany. Electronic address: j.chun@ccb.de.
Marie StichCCB - Cardioangiologisches Centrum Bethanien, Medizinische Klinik 3, Markuskrankenhaus, Frankfurt Am Main, Germany.
Alexander FürnkranzCCB - Cardioangiologisches Centrum Bethanien, Medizinische Klinik 3, Markuskrankenhaus, Frankfurt Am Main, Germany.
Stefano BordignonCCB - Cardioangiologisches Centrum Bethanien, Medizinische Klinik 3, Markuskrankenhaus, Frankfurt Am Main, Germany.
Laura PerrottaCCB - Cardioangiologisches Centrum Bethanien, Medizinische Klinik 3, Markuskrankenhaus, Frankfurt Am Main, Germany.
Daniela DugoCCB - Cardioangiologisches Centrum Bethanien, Medizinische Klinik 3, Markuskrankenhaus, Frankfurt Am Main, Germany.
Fabrizio BolognaCCB - Cardioangiologisches Centrum Bethanien, Medizinische Klinik 3, Markuskrankenhaus, Frankfurt Am Main, Germany.
Boris SchmidtCCB - Cardioangiologisches Centrum Bethanien, Medizinische Klinik 3, Markuskrankenhaus, Frankfurt Am Main, Germany.
Cardiovascular Center Bethanien · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe ideal energy dosing remains unclear in second-generation cryoballoon (CB) pulmonary vein isolation (PVI). We aimed to investigate the effect of an individualized dosing strategy based on time to PVI (TTI).

objectiveThe purpose of this study was to prospectively investigate the safety and efficacy of individualized PVI using the second-generation CB guided by real-time pulmonary vein recordings.

methodsTwo groups were prospectively randomized: ICE-T group: if TTI <75 seconds, then no bonus freeze; and control group: acute PVI followed by 1 empiric bonus freeze. Freeze duration was set to 240 seconds. The primary end point was single procedure sinus rhythm after 12 months (blanking period 3 months). Secondary end points included procedural data, complications, and biomarker release.

resultsIn total, 100 patients with paroxysmal atrial fibrillation were randomized. The primary end point was not different (88% vs 82%). Procedure and fluoroscopy times were significantly shorter in the ICE-T group (70 ± 20 minutes vs 89 ± 21 minutes; P < .001 and 10.6 ± 3.9 minutes vs 12.7 ± 5.5 minutes; P = .03). More complications occurred in the control group (n = 9 vs n = 3) (persistent phrenic nerve injury: n = 1 vs n = 0; transient phrenic nerve injury: n = 5 vs n = 2; esophageal lesions: n = 3 vs n = 1). Postablation troponin T levels were not different (ICE-T group vs control group: 1035 ± 402 ng/L vs 1219 ± 509 ng/L; P = .099), whereas a significantly lower lactic acid dehydrogenase release was observed in the ICE-T group (259 ± 47 U/L vs 282 ± 57 U/L; P = .038). Multivariate analysis identified a mean TTI of >43 seconds as the only independent predictor of recurrent atrial tachyarrhythmia.

conclusionThe individualized CB PVI strategy allows faster atrial fibrillation ablation without affecting the favorable clinical outcome. A short TTI appears to predict freedom from recurrent atrial tachyarrhythmia.

Indexed as

Catheter AblationCryosurgeryIntraoperative ComplicationsPeripheral Nerve InjuriesAgedAtrial FibrillationBiomarkersEsophagusFemaleHumansMaleMiddle AgedPhrenic NervePulmonary VeinsSecondary PreventionTreatment OutcomeBiomarkersAblationAtrial fibrillationCatheter ablationCryoballoonPulmonary vein isolation

Identifiers

PMID27956248
OpenAlexW2560351287

What OpenQuestion holds

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Read underepoch 390

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.