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Not yet recruitingNCT07320274Arc-FITUpdated Jan 6, 2026

ArcFlex Sheath in TAVR Trial

An interventional study of ArcFlex Sheath and ordinary sheath in Valve Disease, Aortic, sponsored by Sun Yat-sen University. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Sex
All
01

Study summary

TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the surgery. Investigators' aim is to evaluate the safety and effectiveness of a variable-bend sheath for the TAVR procedure.

02

Conditions studied

  • Valve Disease, Aortic

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Keywords

  • TAVR
  • Sheath
  • ArcFlex
03

In context

Aortic Valve Disease

231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.

This study's planned enrollment of 180 is above the median of 108 across 116 interventional studies indexed under Aortic Valve Disease.

Browse Aortic Valve Disease studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Judged by a professional cardiologist to require TAVR surgery
  • NYHA ≥ II grade
  • Evaluated by the cardiac team, the peripheral vascular approach is suitable for performing the surgery via the femoral route
  • Expected lifespan is greater than 1 year (5) Patients who can understand the purpose of the trial, voluntarily participate, sign the informed consent form, and are willing to undergo relevant examinations and clinical follow-ups.

Exclusion criteria

Exclusion Criteria:

  • Presence of other valvular diseases requiring concurrent intervention.
  • Anatomical characteristics unsuitable for transcatheter valve implantation.
  • Severe mitral stenosis due to organic causes requiring surgical valve replacement or repair.
  • Hypertrophic obstructive cardiomyopathy (unexplained myocardial hypertrophy >1.5 cm).
  • Acute myocardial infarction within the past 30 days.
  • Intracardiac mass, thrombus, or vegetation indicated by echocardiography.
  • Active infective endocarditis or any other active infection.
  • Intolerance to tolerate anticoagulant or antiplatelet therapy.
  • Coagulopathy or refusal to receive blood transfusion therapy.
  • Known allergy to device materials or contrast agents.
  • Acute peptic ulcer or gastrointestinal bleeding within the past 3 months.
  • Stroke or transient ischemic attack (TIA) within the past 3 months.
  • Requirement for emergency surgical treatment for any reason.
  • Expected life expectancy of less than 12 months due to non-cardiac causes.
  • Severe disabling dementia or inability to perform activities of daily living.
  • Participation in other clinical trials of drugs or medical devices prior to enrollment and not yet reached the primary endpoint of that study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    ArcFlex Sheath

    ArcFlex Sheath

    Device: ArcFlex Sheath

  • Placebo comparator
    control group

    The ordinary sheath

    Device: ordinary sheath

Interventions

  • DeviceArcFlex Sheath

    TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the surgery. Investigators' aim is to evaluate the safety and effectiveness of a variable-bend sheath for the TAVR procedure.

  • Deviceordinary sheath

    ordinary sheath

06

What researchers measure

Primary outcomes

  1. surgical instruments

    The success rate of immediate surgical instruments

    Time frame: 24 hours

Secondary outcomes

  1. 30-day mortality rate

    30-day mortality rate

    Time frame: 30days

  2. One-year mortality rate

    One-year mortality rate

    Time frame: 1 year

07

Study locations

1 site
  • The First Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong, China
08

References and documents

Publications

  • Mao Y, Liu Y, Zhai M, Jin P, Chen F, Yang Y, Zhu G, Yang T, Zhang G, Xu K, Shang X, Zhao Y, Ni B, Li H, Tang M, Jian Z, Yang Y, Zhang H, Wei L, Liu J, Noterdaeme T, Lange R, Guo Y, Pan X, Wu Y, Yang J. Clinical value of aortic arch morphology in transfemoral TAVR: artificial intelligence evaluation. Int J Surg. 2025 Mar 1;111(3):2338-2347. doi: 10.1097/JS9.0000000000002232. PubMed 39869394 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07320274
Lead sponsor
Sun Yat-sen University
Responsible party
Xiao-dong Zhuang (Professor, Sun Yat-sen University) — Principal investigator
First posted
Jan 6, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Dec 30, 2028 (estimated)
Completion
Mar 30, 2030 (estimated)
Last update
Jan 6, 2026

Study contacts

Xiaodong zhuang, MD
Contact
zhuangxd3@mail.sysu.edu.cn
020-89998001

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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