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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Clinical indication for AVR for native valve predominant AR defined as:

‣ 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

• Subject meets the legal minimum age to provide informed consent based on local regulatory requirements

Locations
United States
California
CPMC Sutter Health
RECRUITING
Burlingame
Scripps Health
RECRUITING
La Jolla
Cedar-Sinai Medical Center
RECRUITING
Los Angeles
Florida
BayCare Health
RECRUITING
Clearwater
Georgia
Emory University Hospital
RECRUITING
Atlanta
Piedmont Healthcare
RECRUITING
Atlanta
Michigan
Henry Ford Health
RECRUITING
Detroit
Minnesota
Minneapolis Heart Institute Founcation
RECRUITING
Minneapolis
New York
Cumc/Nyph
RECRUITING
New York
Ohio
The Christ Hospital
RECRUITING
Cincinnati
Texas
Houston Methodist Research Institute
RECRUITING
Houston
Utah
Intermountain Health
RECRUITING
Murray
Virginia
Sentara Norfolk
RECRUITING
Norfolk
Contact Information
Primary
Duane Pinto, MD MPH
pinto@jenavalve.com
949-767-2110
Time Frame
Start Date: 2025-06-18
Estimated Completion Date: 2036-02
Participants
Target number of participants: 1016
Treatments
Experimental: Transcatheter Aortic Valve Replacement (TAVR)
Transcatheter Aortic Valve Replacement (TAVR) using the Trilogy THV System
Other: SAVR
SAVR using commercially available surgical prosthetic valve
Sponsors
Leads: JenaValve Technology, Inc.

This content was sourced from clinicaltrials.gov