Evidence map›Paper›PMID 38095010›Full record

ArticleJACC. Asia2023

Liquid Nitrogen Cryoballoon Ablation System for Paroxysmal Atrial Fibrillation: A Multicenter, Prospective, Single-Arm Clinical Trial.

Zhenning Nie, Dongdong Zhao, Zhongyuan Ren, Cody R Hou, Xi Su, Chenggang Deng, Yan Yao, Kai Tang, Yigang Li, Hua Fu and 7 more

Open access · goldAbstract read
In one paragraph

Article in JACC. Asia, 2023. 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
0.7field-weighted citation impact, top 27% 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.

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, 3 citations in OpenAlex.

  1. Review
  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

17 authors at 9 institutions in 2 countries.

Zhenning NieZhongshan Hospital, Fudan University, Shanghai, China.
Dongdong ZhaoHeart Center, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.
Zhongyuan RenHeart Center, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.
Cody R HouXinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
Xi SuFuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Chenggang DengFuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Yan YaoWuhan Asia Heart Hospital, Wuhan, China.
Kai TangHeart Center, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.
Yigang LiWest China Hospital, Sichuan University, Sichuan, China.
Hua FuFirst Affiliated Hospital of the University of Science and Technology of China, Anhui Provincial Hospital, Anhui, China.
Rui ZengFirst Affiliated Hospital of the University of Science and Technology of China, Anhui Provincial Hospital, Anhui, China.
Zhibing LuZhongnan Hospital of Wuhan University, Wuhan, China.
Hongbing LiFirst Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Hao SuFirst Affiliated Hospital of Wenzhou Medical University, First Provincial Wenzhou Hospital of Zhejiang, Zhejiang, China.
Fangyi XiaoCardiovascular Division, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.
Yawei XuHeart Center, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.
Junbo GeZhongshan Hospital, Fudan University, Shanghai, China.
Tongji University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNUniversity of Science and Technology of China · CNSun Yat-sen University · CNFirst Affiliated Hospital of Xi'an Jiaotong University · CNSichuan University · CNWenzhou Medical University · CNWuhan University · CNXinHua Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Cryoballoon ablation (CBA) has emerged as an effective treatment for atrial fibrillation (AF). Objectives: This study sought to assess the performance of a novel liquid nitrogen-driven CBA system and evaluate its safety and efficacy in the treatment of drug-resistant paroxysmal atrial fibrillation (PAF). Methods: This was a prospective multicenter single-arm clinical trial with 10 participating tertiary hospitals enrolling 176 patients with PAF. All participants received liquid nitrogen-driven CBA developed by the Cryofocus Medtech Company. Scheduled follow-up was performed before discharge and 3 months, 6 months, and 12 months after CBA. The primary endpoints were defined as 1) treatment success (freedom from antiarrhythmic drugs and atrial tachycardia at 12 months after CBA); and 2) immediate success rate of pulmonary vein isolation. The safety endpoint was the incidence of device- and procedure-related adverse events (AEs) and all-cause mortality. Results: A total of 172 participants were included, with an average age of 59.22 ± 9.25 years and 99 (57.56%) of them men. Immediate success rate was 97.67% (95% CI: 94.15%-99.36%) and 12-month treatment success rate was 82.56% (95% CI: 76.89%-88.23%), including a late recurrence rate of 13.61%. Incidences of device- and procedure-related AEs were 2.27% and 25.00%, respectively. Phrenic nerve palsy (PNP) occurred in 6 patients, of which 5 recovered during follow-up. Although the incidence of total severe AEs was 17.05%, including an all-cause mortality of 0.57%, only 1 case of permanent PNP was related to the CBA procedure. Conclusions: This premarketing prospective multicenter single-arm clinical trial demonstrated that the liquid nitrogen cryoablation system is safe and effective in the treatment of PAF.

Indexed as

cryoballoon ablationefficacyliquid nitrogenparoxysmal atrial fibrillationpremarketing trialsafety

Identifiers

PMID38095010
PMCPMC10715880
OpenAlexW4387063817

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.