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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
ALIGN-AR Trial Summary
This trial is collecting information about treatment for people with severe aortic regurgitation, a heart condition where the aortic valve doesn't close tightly, causing blood to leak back into the heart chamber. The preferred treatment is surgery to replace the aortic valve.
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.Check my eligibility
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.See study design
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.
ALIGN-AR Trial 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.
ALIGN-AR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Kidney Injury
All Stroke
All-Cause Mortality at 1 Year
+5 moreSecondary outcome measures
KCCQ
ALIGN-AR 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
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Who is running the clinical trial?
JenaValve Technology, Inc.Lead Sponsor
5 Previous Clinical Trials
985 Total Patients Enrolled
1 Trials studying Aortic Valve Disease
600 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
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment being carried out in numerous facilities across North America?
"This medical study has 33 recruiting sites, including Allegheny-Singer Health Network in Pittsburgh, Memorial Hermann - Texas Medical Center in Houston, and Minneapolis Heart Institute/ Abbott Northwestern in Minneapolis. An additional thirty locations are also accepting patients for this trial."
Answered by AI
Does this medical trial have any openings for participants?
"Evident on clinicaltrials.gov, this research is not currently enrolling participants as the study was first published in May of 2020 and last updated in September 2022. Even though recruitment has ceased, there are 46 other medical studies looking for candidates right now."
Answered by AI
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