Health TrialsbyHealthPanel

ArcFlex Sheath in TAVR Trial

ConditionValve Disease, Aortic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • ArcFlex Sheath

    Device

    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.

  • ordinary sheath

    Device

    ordinary sheath

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: ArcFlex SheathExperimental treatment 1 intervention
Group B: control groupPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: