What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Aortic Valve Replacement Surgery, the preferred treatment for severe Aortic Regurgitation, carries several potential side effects and risks. Common surgical risks include infection, bleeding, and adverse reactions to anesthesia. Specific complications related to valve replacement can include valve dysfunction or failure, blood clots leading to stroke or heart attack, and issues related to the prosthetic valve such as wear and tear or the need for future replacement. Additionally, patients may experience arrhythmias and, in rare cases, complications such as aortic dissection or endocarditis.

What prior FDA approvals exist?

Aortic regurgitation is primarily treated through surgical intervention, specifically aortic valve replacement surgery. This procedure involves replacing the malfunctioning aortic valve to prevent blood leakage and improve heart function. The FDA has approved various types of aortic valve replacement devices, including mechanical valves, bioprosthetic valves, and transcatheter aortic valve replacement (TAVR) systems. These devices are designed to restore proper valve function and are indicated for patients with severe aortic regurgitation who are symptomatic or at risk of heart failure.

What other types of research exist?

One promising novel alternative to aortic valve replacement surgery for aortic regurgitation patients is Transcatheter Aortic Valve Replacement (TAVR). The JenaValve Pericardial TAVR system, as studied in the ALIGN-AR EFS trial, is designed specifically for treating severe aortic regurgitation. This minimally invasive procedure involves placing a new valve within the existing malfunctioning valve via a catheter, reducing the need for open-heart surgery and potentially offering quicker recovery times and fewer complications.

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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)

Must not have

Congenital uni or bicuspid aortic valve morphology

Need for urgent or emergent TAVR procedure for any reason

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 30 days and 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial examines using TAVR with the JenaValve to treat patients with severe Aortic Regurgitation. TAVR is a less invasive procedure that replaces the faulty heart valve through a small cut, helping blood flow correctly. The JenaValve is a new type of heart valve implanted through a specific method.

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.

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.

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 below

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I have symptoms when I do physical activity.

Select...

I have severe leakage in my aortic valve.

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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 was born with a one or two-flap aortic valve.

Select...

I need an urgent heart valve replacement.

Select...

I have severe leakage in my heart's mitral valve.

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I need medication or a device to help my heart pump blood.

Select...

I do not have an active infection or endocarditis.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 days 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

All-Cause Mortality at 30 days

Secondary study objectives

Bleeding & Vascular Complications

Mortality

Peri-Procedural Myocardial Infarction

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcatheter Aortic Valve Replacement (TAVR)Experimental Treatment1 Intervention

TAVR with JenaValve Pericardial Valve and Delivery System

0 / 8Eligibility criteria met

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].