NCT07320274

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
48mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Mar 2030

First Submitted

Initial submission to the registry

September 20, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2030

Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

2.8 years

First QC Date

September 20, 2025

Last Update Submit

December 21, 2025

Conditions

Valve Disease, Aortic

Keywords

TAVRSheathArcFlex

Outcome Measures

Primary Outcomes (1)

  • surgical instruments

    The success rate of immediate surgical instruments

    24 hours

Secondary Outcomes (2)

  • 30-day mortality rate

    30days

  • One-year mortality rate

    1 year

Study Arms (2)

ArcFlex Sheath

EXPERIMENTAL

ArcFlex Sheath

Device: ArcFlex Sheath

control group

PLACEBO COMPARATOR

The ordinary sheath

Device: ordinary sheath

Interventions

ordinary sheathDEVICE

ordinary sheath

control group
ArcFlex SheathDEVICE

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.

ArcFlex Sheath

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Related Publications (1)

  • 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: 39869394RESULT

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Xiaodong zhuang, MD

CONTACT

020-89998001zhuangxd3@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2025

First Posted

January 6, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

March 30, 2030

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)