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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 moreSecondary 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].
[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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study details and have signed the consent form.I have severe leakage in my heart's mitral valve.I need medication or a device to help my heart pump blood.I have severe leakage in my aortic valve.I experience symptoms when doing regular activities due to my heart condition.I am considered high risk for traditional heart valve surgery.You have had a prosthetic aortic valve (made of artificial materials) implanted in the past.I was born with a one or two-flap aortic valve.I do not have an active infection or endocarditis.I need an urgent heart valve replacement.
Research Study Groups:
This trial has the following groups:- Group 1: Transcatheter Aortic Valve Replacement (TAVR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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