Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeijia Medical Technology (Suzhou) Co., Ltd.

About this trial

To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).

Eligibility criteria

Qualifiers

Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;

Age ≥ 18 years;

Jet width ≥ 65% of LVOT

Vena contracta width of > 6 mm

Disqualifiers

Congenital uni- or bicuspid aortic valve morphology;

Previous prosthetic aortic valve (bioprosthesis or mechanical) implant;

Mitral regurgitation or Tricuspid regurgitation> moderate;

Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure;

Trial design

Treatments tested in this trial

  • TaurusTrio™ Heart Valve System

Treatment groups

116 Participants
are divided into 1 treatment group