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Not yet recruiting NCT07320274

ArcFlex Sheath in TAVR Trial

No phase Interventional Valve Disease, Aortic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ArcFlex Sheath, ordinary sheath.
Who it may be relevant to
Registry conditions: Valve Disease, Aortic. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ArcFlex Sheath in TAVR Trial(Arc-FIT)

Overview

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.

Interventions

  • Device ArcFlex 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.
  • Device ordinary sheath
    ordinary sheath

Primary outcome measures

  • surgical instruments [Time frame: 24 hours]
Secondary outcome measures (2)
  • 30-day mortality rate [Time frame: 30days]
  • One-year mortality rate [Time frame: 1 year]

Eligibility criteria

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Sun Yat-sen University — Guangzhou

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. PMID 39869394

Identifiers

NCT: NCT07320274 · Arc-FIT trial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗