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Transcatheter Aortic Valve Replacement (TAVR)
JenaValve Pericardial TAVR System for Aortic Regurgitation
N/A
Waitlist Available
Led By Torsten P. Vahl, 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 symptomatic according to NYHA functional class II or higher
Patient with severe aortic regurgitation (AR)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 days and 1 year
Awards & highlights
Study Summary
This trialgathers info on treatment for severe aortic regurgitation, a heart valve condition. Symptoms incl. fatigue & shortness of breath. Surgery is the preferred treatment.
Who is the study for?
This trial is for patients with severe aortic regurgitation, who are at high risk for traditional open-heart valve replacement surgery. They should have symptoms that affect their daily activities (NYHA class II or higher). Participants must understand the study and agree to its terms with written consent. Those with abnormal aortic valve morphology, previous valve replacements, active infections, urgent heart conditions, or severe mitral regurgitation cannot join.Check my eligibility
What is being tested?
The ALIGN-AR EFS TRIAL is evaluating the JenaValve Pericardial TAVR System as a treatment option for severe Aortic Regurgitation. This condition causes blood to leak back into the heart chamber due to an improperly closing valve. The trial aims to gather data on this less invasive alternative to open-heart surgery.See study design
What are the potential side effects?
While specific side effects of the JenaValve system aren't listed here, similar procedures may include risks like bleeding, blood vessel complications, irregular heartbeats, stroke, infection at the catheter site and potential need for permanent pacemaker.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have symptoms when I do physical activity.
Select...
I have severe leakage in my aortic valve.
Select...
I am considered high risk for traditional heart valve surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 30 days and 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 days and 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All-Cause Mortality at 30 days
Secondary outcome measures
Bleeding & Vascular Complications
Mortality
Peri-Procedural Myocardial Infarction
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Transcatheter Aortic Valve Replacement (TAVR)Experimental Treatment1 Intervention
TAVR with JenaValve Pericardial Valve and Delivery 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 is the most common treatment for severe Aortic Regurgitation. This surgical intervention replaces the malfunctioning aortic valve with a prosthetic valve, ensuring proper closure and preventing blood from leaking back into the heart chamber.
By maintaining efficient blood flow and reducing the heart's workload, this treatment improves heart function and alleviates symptoms such as fatigue and shortness of breath. This mechanism is crucial for AR patients as it directly addresses the root cause of their condition, significantly enhancing their quality of life.
[Surgical treatment of aortic valve stenosis].
[Surgical treatment of aortic valve stenosis].
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Who is running the clinical trial?
JenaValve Technology, Inc.Lead Sponsor
5 Previous Clinical Trials
1,065 Total Patients Enrolled
Torsten P. Vahl, MDPrincipal InvestigatorNew York-Presbyterian/ Columbia University Medical Center
1 Previous Clinical Trials
180 Total Patients Enrolled
Vinod H. Thourani, MDPrincipal InvestigatorPiedmont Healthcare
3 Previous Clinical Trials
587 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was born with a one or two-flap aortic valve.I have symptoms when I do physical activity.I need an urgent heart valve replacement.I have severe leakage in my heart's mitral valve.I have severe leakage in my aortic valve.I am considered high risk for traditional heart valve surgery.You have had a prosthetic aortic valve (made of metal or tissue) implanted in the past.I need medication or a device to help my heart pump blood.I do not have an active infection or endocarditis.
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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