Evidence map›Paper›PMID 38840770›Full record

ArticleHeart rhythm O22024

A randomized controlled trial of the size-adjustable cryoballoon vs conventional cryoballoon for paroxysmal atrial fibrillation: The CONTRAST-CRYO II trial rationale and design.

Iwanari Kawamura, Shinsuke Miyazaki, Yukihiro Inamura, Junichi Nitta, Atsushi Kobori, Kohki Nakamura, Masato Murakami, Tomofumi Nakamura, Osamu Inaba, Yukio Sekiguchi and 6 more

Abstract read
In one paragraph

Article in Heart rhythm O2, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

16 authors.

Iwanari KawamuraDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University Hospital, Tokyo, Japan.
Shinsuke MiyazakiDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University Hospital, Tokyo, Japan.
Yukihiro InamuraDepartment of Cardiology, Japanese Red Cross Saitama Hospital, Saitama, Japan.
Junichi NittaDepartment of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.
Atsushi KoboriDepartment of Cardiology, Kobe City Medical Center General Hospital, Hyogo, Japan.
Kohki NakamuraDivision of Cardiology, Gunma Prefectural Cardiovascular Center, Gunma, Japan.
Masato MurakamiDepartment of Cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan.
Tomofumi NakamuraDepartment of Cardiology, Nagoya Heart Center, Aichi, Japan.
Osamu InabaDepartment of Cardiology, Japanese Red Cross Saitama Hospital, Saitama, Japan.
Yukio SekiguchiDepartment of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.
Sou AsanoDepartment of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.
Yasuhiro SasakiDepartment of Cardiology, Kobe City Medical Center General Hospital, Hyogo, Japan.
Shingo MizunoDepartment of Cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan.
Shigeto NaitoDivision of Cardiology, Gunma Prefectural Cardiovascular Center, Gunma, Japan.
Akihiro HirakawaDepartment of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.
Tetsuo SasanoDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University Hospital, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Pulmonary vein isolation (PVI) with cryoballoon technology is a well-established therapy for treatment of atrial fibrillation (AF). Recently, a size-adjustable cryoballoon (POLARx Objective: The purpose of this study was to perform a randomized clinical trial to evaluate the safety and efficacy of this novel cryoballoon compared to the conventional cryoballoon. Methods: The CONTRAST-CRYO II trial is a multicenter, prospective, open-label, randomized controlled trial in which 214 patients with paroxysmal AF will be randomized 1:1 to cryoballoon ablation with either a conventional cryoballoon (Arctic Front Advance Results: The primary endpoint of this study will be the incidence of phrenic nerve injury. Secondary endpoints include procedural success, chronic success through 12 months, procedure-related adverse events, biophysiological parameters during applications for each pulmonary vein (PV), total procedural and fluoroscopy times, level of PVI and isolation area, and probability of non-PV foci initiating AF. Conclusion: The CONTRAST-CRYO II trial is a multicenter, prospective, randomized controlled trial designed to assess the safety and efficacy of the POLARx FIT vs the Arctic Front Advance Pro. The findings from this trial will provide additional utility data on the efficacy of the size-adjustable cryoballoon for isolating PVs in patients with paroxysmal AF.

Indexed as

Atrial fibrillationCatheter ablationComplicationCryoballoonPhrenic nerve injury

Identifiers

PMID38840770
PMCPMC11148497

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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.