Evidence map›Paper›PMID 42298602›Full record

Trial reportJournal of cardiothoracic surgery2026

Two-year outcomes of transcatheter aortic valve replacement with the vitaflow libertyTM system in high-surgical-risk patients with severe aortic stenosis.

Shasha Chen, Zhi Zhan, Dandan Chen, Qinchun Jin, Yuan Zhang, Xiaochun Zhang, Wenzhi Pan, Daxin Zhou, Junbo Ge

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of cardiothoracic surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04414878 (A Prospective, Multicenter, Single-arm, Objective Performance Clinical Investigation For Evaluation of the Safety and Effectiveness of MicroPort™ CardioFlow VitaFlow ™ II Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT04414878 narecruitingnot on this map

A Prospective, Multicenter, Single-arm, Objective Performance Clinical Investigation For Evaluation of the Safety and Effectiveness of MicroPort™ CardioFlow VitaFlow ™ II Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis

TypeinterventionalSponsorShanghai MicroPort CardioFlow Medtech Co., Ltd.Ran2018 to 2027Enrolled145ConditionsAortic StenosisArmsVitaFlow™ II Transcatheter Aortic Valve System
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Shasha Chen *Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.
Zhi Zhan *Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.
Dandan ChenDepartment of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.
Qinchun JinDepartment of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.
Yuan ZhangDepartment of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.
Xiaochun ZhangDepartment of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.
Wenzhi PanDepartment of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China. peden@sina.com.
Daxin ZhouDepartment of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China. zhou.daxin@zs-hospital.sh.cn.
Junbo GeDepartment of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China.

Funding

Scientific research plan project of Shanghai science and technology committee 19DZ1930202
6 · The paper itself

Abstract

backgroundMid-term clinical evidence for the VitaFlow LibertyTM transcatheter aortic valve system in anatomically complex populations is limited.

methodsThis was a prospective, multicenter, single-arm Objective Performance Criteria study performed at 22 Chinese sites, with follow-up at 30 days, 6 months, 1 year, and annually through 5 years. The prespecified primary endpoint of the parent study was 1-year all-cause mortality. Other clinical events were adjudicated according to Valve Academic Research Consortium-2 definitions.

resultsA total of 163 patients underwent transcatheter aortic valve replacement (TAVR) with the VitaFlow LibertyTM system. The mean age was 76.8 ± 5.0 years, 65.0% were male, the mean STS-PROM score was 7.87 ± 2.70, and 46.6% had bicuspid aortic valve anatomy. At 2 years, all-cause mortality was 13.5%, any stroke occurred in 7.6%, and new permanent pacemaker implantation was required in 19.5%. Mean aortic valve gradient improved from 59.22 ± 19.76 mmHg at baseline to 9.04 ± 6.07 mmHg at 2 years, and effective orifice area improved from 0.57 ± 0.21 cm

conclusionsTAVR with the VitaFlow LibertyTM system demonstrated favorable 2-year safety and efficacy in a challenging population, with sustained hemodynamic performance.

trial registrationNCT04414878.

Indexed as

Aortic ValveAortic Valve StenosisHeart Valve ProsthesisTranscatheter Aortic Valve ReplacementAgedAged, 80 and overFemaleFollow-Up StudiesHumansMaleProspective StudiesProsthesis DesignRisk FactorsSeverity of Illness IndexTreatment OutcomeAortic stenosisBicuspid aortic valveParavalvular regurgitationTranscatheter aortic valve replacement

Identifiers

PMID42298602
PMCPMC13508350

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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.