Evidence map›Paper›PMID 26283655›Full record

Trial reportCirculation2015

Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: The Prospective, Randomized, Controlled, Noninferiority FreezeAF Study.

Armin Luik, Andrea Radzewitz, Meinhard Kieser, Marlene Walter, Peter Bramlage, Patrick Hörmann, Kerstin Schmidt, Nicolas Horn, Maria Brinkmeier-Theofanopoulou, Kevin Kunzmann and 4 more

Registry-linked trialOpen access · greenAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00774566 (A Comparison of Isolating the Pulmonary Veins With the Cryoballoon Catheter Versus Radiofrequency Segmental Isolation), which is not on this map. Cited by 125 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
125citing papers in PubMed, 12 pooled it
24.4field-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.

NCT00774566 phase4completednot on this map

A Comparison of Isolating the Pulmonary Veins With the Cryoballoon Catheter Versus Radiofrequency Segmental Isolation:a Randomized Controlled Prospective Non-inferiority Trial

TypeinterventionalSponsorStaedtisches Klinikum KarlsruheRan2008 to 2014Enrolled322ConditionsAtrial FibrillationArmsPV-Isolation RF, PV-Isolation Cryo
3 · Its place in the literature

Who cites it

125 citing papers in PubMed, 12 syntheses or guidelines pooled it, 267 citations in OpenAlex.

  1. Pooled it
  2. Efficacy and safety of high-power short-duration ablation for atrial fibrillation: a systematic review and meta-analysis of randomized controlled trials.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Second-generation cryoballoon vs. contact-force sensing radiofrequency catheter ablation in atrial fibrillation: a meta-analysis of randomized controlled trials.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2021
    Pooled it
  6. Pooled it
  7. Cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation: a meta-analysis of randomized controlled trials.Clinical research in cardiology : official journal of the German Cardiac Society · 2018
    Pooled it
  8. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation.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 · 2018
    Guideline
  9. Pooled it
  10. Comparison of catheter ablation for paroxysmal atrial fibrillation between cryoballoon and radiofrequency: a meta-analysis.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2017
    Pooled it
  11. Pooled it
  12. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society.Heart rhythm · 2012
    Guideline
  13. Trial
  14. 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
  15. Trial
  16. Trial
  17. Article
  18. Article
  19. Pulsed field ablation vs. thermal ablation for pulmonary vein isolation: a network 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 · 2026
    Article
  20. Article

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

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Armin LuikFrom Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.). armin.luik@klinikum-karlsruhe.de.
Andrea RadzewitzFrom Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Meinhard KieserFrom Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Marlene WalterFrom Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Peter BramlageFrom Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Patrick HörmannFrom Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Kerstin SchmidtFrom Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Nicolas HornFrom Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Maria Brinkmeier-TheofanopoulouFrom Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Kevin KunzmannFrom Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Tobias RiexingerFrom Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Gerhard SchymikFrom Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Matthias MerkelFrom Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Claus SchmittFrom Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Heidelberg University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is a lack of data on the comparative efficacy and procedural safety of open irrigated radiofrequency (RF) and cryoballoon catheter (CB) ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. METHODS AND

resultsIn a prospective, noninferiority study, 315 patients were randomly assigned to RF (n=159) or CB (n=156) ablation. The primary end point was freedom from atrial arrhythmia with absence of persistent complications. Patients were largely comparable between groups with more vascular disease in the RF group (8.2% versus 2.6% for CB; P=0.028). The primary end point at 12 months was achieved by 70.7% with RF and 73.6% with CB (multiple procedure success), including 31 redo procedures in each group (19.5% of RF versus 19.9% of CB; P=0.933). For the intention-to-treat population, noninferiority of CB was revealed for the predefined inferiority margin (risk difference, 0.029; 95% confidence interval, -0.074 to 0.132; P<0.001). Rates at 6 months were 63.1% and 64.1% for the RF and CB groups (single procedure success), and noninferiority was confirmed (risk difference, 0.010; 95% confidence interval, -0.097 to 0.116; P=0.002). Periprocedural complications for the index procedure were more frequent in the CB group (5.0% RF, 12.2% CB; P=0.022) with a significant difference in phrenic nerve palsies (0% RF, 5.8% CB; P=0.002).

conclusionThis large, prospective, randomized, controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00774566.

Indexed as

Adrenergic beta-AntagonistsAgedAnticoagulantsAtrial FibrillationCardiovascular DiseasesCatheter AblationCombined Modality TherapyComorbidityCryosurgeryDiabetes MellitusElectrocardiography, AmbulatoryFemaleHumansImaging, Three-DimensionalIntraoperative ComplicationsMaleAdrenergic beta-AntagonistsAnticoagulantsarrhythmias, cardiacatrial fibrillationcatheter ablation

Identifiers

PMID26283655
PMCPMC4590523
OpenAlexW2118862773

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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.