ArcFlex Sheath in TAVR Trial (Arc-FIT)

ArcFlex Sheath in TAVR Trial(Arc-FIT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Valve Disease, Aortic
• Intervention / Treatment: Device: ArcFlex Sheath; Device: ordinary sheath

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: xiaodong zhuang, MD; Phone Number: 020-89998001; Email: zhuangxd3@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Sun Yat-sen University
      • Contact: xiaodong zhuang, MD; Phone Number: 020-89998001; Email: zhuangxd3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ArcFlex Sheath	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.
Placebo Comparator: control group; The ordinary sheath	Device: ordinary sheath; ordinary sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical instruments	The success rate of immediate surgical instruments	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality rate	30-day mortality rate	30days
One-year mortality rate	One-year mortality rate	1 year

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): March 30, 2030

Study Registration Dates

• First Submitted: September 20, 2025
• First Submitted That Met QC Criteria: December 21, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: TAVR; Sheath; ArcFlex
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: Arc-FIT trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No