Health TrialsbyHealthPanel

ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™

ConditionsAortic RegurgitationAortic Valve InsufficiencyAortic Insufficiency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorJenaValve Technology, Inc.

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Device

    Transcatheter Aortic Valve Replacement (TAVR) with Trilogy Device

  • SAVR

    Device

    SAVR using commercially available surgical prosthetic valves.

Treatment groups

1,016 Participants
are divided into 2 treatment groups
Group A: Transcatheter Aortic Valve Replacement (TAVR)Experimental treatment 1 intervention
Group B: SAVROther 1 intervention

Trial outcomes

Primary outcomes

1

All-Cause Mortality

all-cause mortality at 12 months

Time frame
12 months
2

All stroke

Number of patients that had stroke

Time frame
12 months
3

unplanned cardiac rehospitalization

Number of patients who had unplanned cardiac rehospitalization

Time frame
12 months

Secondary outcomes

1

Length of index hospitalization

comparing TAVR length of index hospitalization with SAVR

Time frame
pre-intervention/procedure surgery
2

Echocardiographic effective orifice area

comparing TAVR Echocardiographic effective orifice area with SAVR

Time frame
30 days
3

Moderate or greater patient prosthesis mismatch as measured by echo

comparing TAVR moderate or greater patient prosthesis mismatched with SAVR

Time frame
30 days or immediately after the intervention/procedure
4

Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS)

comparing change in KCCQ-OS in TAVR with SAVR. the minimum and maximum values vary based on the questionnaire. Higher scores mean better outcome.

Time frame
30 days

Other outcomes

Sponsors and contacts

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

JenaValve Technology, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now