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

Locations

19
Beijing Anzhen Hospital215025, BeijingBeijing Municipality, China
Fu Wai Hospital, Beijing, China BeijingBeijing Municipality, China
Fujian Medical University Union Hospital FuzhouFujian, China
XiaMen Cardiovascular Hospital XiaMen University XiamenFujian, China

Sponsors and collaborators

Peijia Medical Technology (Suzhou) Co., Ltd.

Lead sponsor