The JenaValve ALIGN-AR Pivotal Trial

Not Applicable

Active, not recruiting

• Conditions: Aortic Valve Insufficiency; Aortic Insufficiency; Aortic Valve Disease; Aortic Regurgitation

• Registration Number: NCT04415047
• Lead Sponsor: JenaValve Technology, Inc.

Brief 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.

Study Timeline

• Study Start: 2020-05-22
• Study First Submitted: 2020-05-31
• Study First Submitted QC: 2020-05-31
• Study First Posted: 2020-06-04
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-07
• Last Update Posted: 2022-09-13
• Primary Completion: 2023-08-29
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Patient with severe aortic regurgitation (AR).
• Patient at high risk for open surgical valve replacement
• Patient symptomatic according to NYHA functional class II or higher
• The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.

Exclusion Criteria

• Congenital uni or bicuspid aortic valve morphology
• Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
• Endocarditis or other active infection
• Need for urgent or emergent TAVR procedure for any reason
• Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
• Severe mitral regurgitation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
All Stroke	30 days	Number of patients that had a stroke
Acute Kidney Injury	30 days	Number of patients that had these events
Major Vascular Complications	30 days	Number of patients that had these events
Surgery/intervention related to the device	30 days	Number of patients that had these events
Permanent pacemaker implantation	30 days	Number of patients that had these events
All-Cause Mortality at 1 Year	1 year	All-cause mortality within the first 12 months post index procedure
Total aortic regurgitation	30 days	Number of patients that had these events
Major Bleeding	30 days	Number of patients that had any of these events

Secondary Outcome Measures

Name	Time	Method
KCCQ	1 year	KCCQ Improvement

Trial Locations

Locations (30)

TMC HealthCare & PIMA Heart; 🇺🇸 Tucson, Arizona, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Scripps Hospital; 🇺🇸 San Diego, California, United States

California Pacific Medical Center Research Institute; 🇺🇸 San Francisco, California, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Morton Plant/ BayCare Health; 🇺🇸 Clearwater, Florida, United States

Piedmont Healthcare; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health; 🇺🇸 Oak Lawn, Illinois, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Scroll for more (20 remaining)