What side effects are associated with this type of intervention?

Aortic Valve Replacement Surgery, a common treatment for Aortic Valve Disease, carries several potential side effects and risks. These include general surgical risks such as infection, bleeding, and adverse reactions to anesthesia. Specific to the valve replacement, patients may experience valve malfunction, blood clots, and may require lifelong anticoagulation therapy to prevent thromboembolic events. Other complications can include arrhythmias, stroke, and in rare cases, valve-related infections such as endocarditis.

What prior FDA approvals exist?

The FDA has approved several treatments for Aortic Valve Disease, particularly focusing on surgical aortic valve replacement. Traditional surgical aortic valve replacement (SAVR) involves the replacement of the malfunctioning aortic valve with a prosthetic valve, which can be either mechanical or bioprosthetic. Additionally, transcatheter aortic valve replacement (TAVR) has been approved for patients who are at high or intermediate risk for open-heart surgery. TAVR involves the use of devices such as the Edwards SAPIEN valve and Medtronic's CoreValve. These treatments aim to restore proper valve function and prevent blood leakage, improving patient outcomes.

What other types of research exist?

One promising alternative to traditional aortic valve replacement surgery is the use of transcatheter aortic valve replacement (TAVR). TAVR is a minimally invasive procedure that involves inserting a new valve within the diseased aortic valve via a catheter, typically through the femoral artery. This method has shown to be effective for patients who are at high or intermediate risk for open-heart surgery. Another novel approach is the use of the JenaValve, which is currently being evaluated in clinical trials for its efficacy in treating symptomatic severe aortic regurgitation. These alternatives offer less invasive options with potentially quicker recovery times and fewer complications compared to traditional surgery.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

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 Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve 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 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].