JenaValve Trilogy Transcatheter Heart Valve System Versus Surgical Valve Replacement in Aortic Regurgitation

What is the Purpose of this Study?

The purpose of this study is to determine whether an experimental device called the Trilogy Transcatheter Heart Valve (THV) System is as effective as surgical valve replacement (SAVR) in treating moderate-to-severe or severe aortic regurgitation (AR) requiring replacement of the native aortic valve. Aortic regurgitation is a condition in which the heart’s aortic valve does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of AR may include fatigue and shortness of breath. Participants will be randomly assigned to 1 of 2 groups. One group will be treated with the transcatheter aortic valve replacement (TAVR) procedure, which is a cardiovascular procedure that uses small cuts and flexible tube through blood vessels to reach the heart. The other group will undergo the surgical aortic valve replacement (SAVR) procedure using standard surgical valves, which is placed during an open-heart surgery to replace the aortic valve.


Eligibility

  • 1. Clinical indication for AVR for native valve predominant AR defined as:
  • 1. 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
  • 2. 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
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Study to Assess Safety and Effectiveness of the JenaValve Trilogy? Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients with Aortic Regurgitation

Study Details
Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III/IV

IRB Number

STUDY00003984

ClinicalTrials.gov ID

NCT06608823

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III/IV

IRB Number

JVT24001

ClinicalTrials.gov ID

NCT06608823

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org