ArcFlex Sheath in TAVR Trial (Arc-FIT)

Sun Yat-sen University

Status: Begins enrollment this month

Conditions: Valve Disease, Aortic

Treatments: Device: ordinary sheath; Device: ArcFlex Sheath

Study type: Interventional

Funder types: Other

Identifiers

NCT07320274

Arc-FIT trial

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups, including a placebo group

ArcFlex Sheath

Experimental group

Description:

ArcFlex Sheath

Treatment:

Device: ArcFlex Sheath

control group

Placebo Comparator group

Description:

The ordinary sheath

Treatment:

Device: ordinary sheath