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
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
Treatments tested in this trial
- ArcFlex Sheath
- ordinary sheath
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov