Health Trials

About this trial

To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)

Eligibility criteria

Qualifiers

Class I or II indication for AVR according to ACC/AHA or ESC/EACTS guidelines with moderate to severe or severe AR (Grade ≥3+) on transthoracic echocardiography, transesophageal echocardiography or cardiac MRI as assessed by the core laboratory OR

AR severity that remains indeterminate despite core laboratory review of all imaging including at least one advanced imaging modality (TEE or cardiac MRI) AND evidence of left ventricular damage* from AR with unanimous agreement from the local heart team, an independent clinical evaluation committee and the CRB that the symptomatic subject (NYHA II or greater) will benefit from SAVR for AR

The subject is a candidate for TAVR using the Trilogy THV system and SAVR using a commercially approved bioprosthetic heart valve

Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits

Disqualifiers

Confirmed moderate (2+) or less AR severity by core laboratory evaluation

Estimated life expectancy of less than 24 months due to associated non- cardiac comorbid conditions

Subject is high-risk for SAVR as determined by the local heart team

Subject refuses SAVR as a treatment option

Trial design

Treatments tested in this trial

  • Transcatheter Aortic Valve Replacement (TAVR) using Trilogy THV System
  • SAVR

Treatment groups

1,016 Participants
are divided into 2 treatment groups

Locations

28
California
CPMC Sutter Health94010, Burlingame United States
Scripps Health92037, La Jolla United States
Cedars-Sinai Medical Center90048, Los Angeles United States
Los Robles Medical Center91360, Thousand Oaks United States

Sponsors and collaborators

JenaValve Technology, Inc.

Lead sponsor

Source ClinicalTrials.gov