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Heart Valve Replacement

JenaValve Trilogy System for Aortic Regurgitation (ALIGN-AR Trial)

N/A
Waitlist Available
Led By Stephan Baldus, MD
Research Sponsored by JenaValve Technology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient with severe aortic regurgitation (AR)
Patient symptomatic according to NYHA functional class II or higher
Must not have
Severe mitral regurgitation
Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial examines using a new heart valve replacement procedure to treat patients with severe Aortic Regurgitation. The procedure replaces the faulty heart valve to improve blood flow and reduce symptoms like fatigue and shortness of breath. The new valve is designed to be self-expanding and has a specific mechanism for secure placement.

Who is the study for?
This trial is for patients with severe aortic regurgitation who are at high risk for open heart surgery and show symptoms like fatigue and shortness of breath. They must be informed about the study, agree to its terms, and have given written consent. People with previous aortic valve replacements, severe mitral regurgitation, certain congenital heart conditions, active infections or those in need of urgent heart procedures cannot participate.
What is being tested?
The JenaValve ALIGN-AR Pivotal Trial is testing the JenaValve Trilogy Heart Valve System as a treatment option for symptomatic severe Aortic Regurgitation (AR). This condition causes blood to leak back into the heart chamber because the valve doesn't close tightly.
What are the potential side effects?
While specific side effects are not listed here, typical risks associated with valve replacement systems can include bleeding, blood vessel complications, irregular heartbeat rhythms (arrhythmias), stroke, infection around the new valve (endocarditis), or even death.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe leakage in my aortic valve.
Select...
I experience symptoms when doing regular activities due to my heart condition.
Select...
I am considered high risk for traditional heart valve surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe leakage in my heart's mitral valve.
Select...
I need medication or a device to help my heart pump blood.
Select...
I was born with a one or two-flap aortic valve.
Select...
I do not have an active infection or endocarditis.
Select...
I need an urgent heart valve replacement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acute Kidney Injury
All Stroke
All-Cause Mortality at 1 Year
+5 more
Secondary study objectives
KCCQ

Trial Design

1Treatment groups
Experimental Treatment
Group I: Transcatheter Aortic Valve Replacement (TAVR)Experimental Treatment1 Intervention
TAVR with JenaValve Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Aortic Valve Replacement Surgery involves replacing the malfunctioning aortic valve with a prosthetic valve to restore proper valve function and prevent blood leakage. This treatment is crucial for patients as it alleviates symptoms like fatigue and shortness of breath, improves cardiac function, and enhances overall quality of life. It also prevents the progression of heart failure and other complications associated with aortic regurgitation and stenosis.
[Surgical treatment of aortic valve stenosis].

Find a Location

Who is running the clinical trial?

JenaValve Technology, Inc.Lead Sponsor
7 Previous Clinical Trials
2,051 Total Patients Enrolled
2 Trials studying Aortic Valve Disease
650 Patients Enrolled for Aortic Valve Disease
Stephan Baldus, MDPrincipal InvestigatorHerzzentrum der Universität zu Köln
4 Previous Clinical Trials
907 Total Patients Enrolled
1 Trials studying Aortic Valve Disease
600 Patients Enrolled for Aortic Valve Disease
Vinod H. Thourani, MDPrincipal InvestigatorPiedmont Healthcare
3 Previous Clinical Trials
507 Total Patients Enrolled

Media Library

JenaValve Pericardial TAVR System (Heart Valve Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT04415047 — N/A
Aortic Valve Disease Research Study Groups: Transcatheter Aortic Valve Replacement (TAVR)
Aortic Valve Disease Clinical Trial 2023: JenaValve Pericardial TAVR System Highlights & Side Effects. Trial Name: NCT04415047 — N/A
JenaValve Pericardial TAVR System (Heart Valve Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04415047 — N/A
~34 spots leftby Oct 2025