NCT04415047

The JenaValve ALIGN-AR Pivotal Trial

A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: JenaValve Technology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.

Detailed description

This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat symptomatic severe aortic regurgitation.

Conditions

• Aortic Regurgitation
• Aortic Valve Insufficiency
• Aortic Insufficiency
• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	JenaValve Trilogy Heart Valve System	TAVR with JenaValve Trilogy Heart Valve System

Timeline

• Start date: 2020-05-22
• Primary completion: 2023-08-29
• Completion: 2028-08-01
• First posted: 2020-06-04
• Last updated: 2022-09-13

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated device study