Evidence map›Paper›PMID 28545407›Full record

Trial reportBMC cardiovascular disorders2017

Cryoballoon vs. open irrigated radiofrequency ablation for paroxysmal atrial fibrillation: long-term FreezeAF outcomes.

Armin Luik, Kevin Kunzmann, Patrick Hörmann, Kerstin Schmidt, Andrea Radzewitz, Peter Bramlage, Thomas Schenk, Gerhard Schymik, Matthias Merkel, Meinhard Kieser and 1 more

Registry-linked trialOpen access · goldAbstract readComparative StudyEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in BMC cardiovascular disorders, 2017. 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 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 17% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Current Balloon Devices for Ablation of Atrial Fibrillation.Reviews in cardiovascular medicine · 2024
    Review
  10. Article
  11. Pulmonary vein isolation by visually guided laser balloon ablation: single-center 5-year follow-up results.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2023
    Observational
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
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

11 authors at 3 institutions in 1 country.

Armin LuikMedizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany. armin.luik@klinikum-karlsruhe.de.
Kevin KunzmannInstitute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
Patrick HörmannMedizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany.
Kerstin SchmidtMedizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany.
Andrea RadzewitzMedizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany.
Peter BramlageInstitute for Pharmacology and Preventive Medicine, Mahlow, Germany.ORCID 0000-0002-4121-6866
Thomas SchenkMedizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany.
Gerhard SchymikMedizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany.
Matthias MerkelMedizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany.
Meinhard KieserInstitute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
Claus SchmittMedizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany.
Städtisches Klinikum Karlsruhe · DEHeidelberg University · DEIPPMed (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEffective treatment of paroxysmal atrial fibrillation (AF) is essential for reducing the risk of stroke and heart failure. Cryoballoon (CB) ablation has been developed as an alternative to the use of radiofrequency (RF) energy for electrical isolation of the pulmonary veins. Herein, we provide long-term data regarding the efficacy of CB ablation in comparison to RF.

methodsFreezeAF was a randomised non-inferiority study comparing CB ablation with RF ablation for the treatment of patients with drug-refractory paroxysmal AF. Procedural success for the long-term follow-up (30 months) was defined as freedom from AF with an absence of persistent complications.

resultsOf the 315 patients that were randomised and received catheter ablation, 292 (92.7%) completed the 30-month follow-up (147 in the RF group and 145 in the CB group). The baseline characteristics of the RF and CB groups were similar. Single-procedure success was achieved by 40% of patients in the RF group and 42% of the CB group (p < 0.001 for non-inferiority). When including re-do procedures in the analysis, the multiple procedure success rate was 72% in the RF group and 76% in the CB group.

conclusionThe data provide long-term evidence that CB ablation is non-inferior to RF ablation, with high proportions of patients reporting freedom from AF 30 months after the index procedure.

trial registrationClinicalTrials.gov Identifier: NCT00774566 ; first registered October 16, 2008; first patient included October 20, 2008.

Indexed as

CryosurgeryTherapeutic IrrigationAgedAtrial FibrillationCatheter AblationDisease-Free SurvivalFemaleGermanyHumansMaleMiddle AgedProspective StudiesPulmonary VeinsRecurrenceTime FactorsTreatment OutcomeAtrial fibrillationCatheter ablationCryoablationCryoballoonPulmonary vein isolationRadiofrequency

Identifiers

PMID28545407
PMCPMC5445510
OpenAlexW2617662803

What OpenQuestion holds

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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.