What side effects are associated with this type of intervention?

Valve-in-Valve Transcatheter Aortic Valve Replacement (ViV-TAVR) for treating Aortic Valve Stenosis can lead to several side effects. Common complications include vascular issues, bleeding, and arrhythmias. There is also a risk of stroke, kidney injury, and paravalvular leak. Additionally, access site complications such as infection or hematoma may occur. These side effects are similar to those seen in other TAVR procedures.

What prior FDA approvals exist?

The FDA has approved several transcatheter aortic valve replacement (TAVR) devices for the treatment of aortic valve stenosis, particularly for patients who are at high or prohibitive surgical risk. Notable FDA-approved TAVR devices include the Edwards SAPIEN valve series and the Medtronic CoreValve series. These devices are used to replace a stenotic aortic valve without the need for open-heart surgery. The ViV-TAVR procedure, which involves replacing a failing bioprosthetic valve with a transcatheter valve, is an extension of this technology and has shown promise in clinical trials for patients with degenerated bioprosthetic valves.

What other types of research exist?

Promising novel alternatives to ViV-TAVR for Aortic Valve Stenosis patients in 2024 include: 1) Next-generation transcatheter aortic valve replacement (TAVR) devices with improved designs for better durability and reduced complications. 2) Minimally invasive surgical aortic valve replacement (SAVR) techniques that offer quicker recovery times and reduced surgical risks. 3) Emerging percutaneous aortic valve repair techniques, such as leaflet modification or annular stabilization, which may provide options for patients not suitable for valve replacement. 4) Advanced imaging and procedural planning technologies that enhance the precision and outcomes of valve interventions.

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Valve Function Assessment After TAVR for Aortic Valve Stenosis (ECHOCATH Trial)

N/A

Recruiting

Led By Josep Rodés-Cabau, MD

Research Sponsored by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve procedure by the Heart Team

Surgical stented bioprosthetic valve (label size ≤25 mm)

Must not have

Stentless or sutureless surgical valves

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 1-year follow-up (yearly up to 5 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new way to evaluate heart valve replacements in patients with small failing valves. It uses a minimally invasive procedure to place a new valve inside the old one and compares two methods of checking how well the new valve works.

Who is the study for?

This trial is for patients with a failing surgical aortic valve who need a valve-in-valve procedure. They must have severe stenosis or regurgitation, and be suitable for the SAPIEN 3 Ultra valve. Excluded are those with non-stented valves, certain bioprostheses brands, high risk of coronary obstruction, or unable to consent.

What is being tested?

The study compares Doppler-echocardiography versus catheterization measurements in assessing heart valve performance after ViV-TAVR. It aims to determine which method gives more accurate data on the condition of the replaced valves.

What are the potential side effects?

While not directly related to side effects, there may be risks associated with both Doppler-echocardiography and invasive hemodynamic measurements such as discomfort or complications from catheter use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My heart team approved me for a valve-in-valve procedure due to severe valve issues.

Select...

I have a small surgical heart valve implant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My heart valve surgery did not use stents or sutures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 1-year follow-up (yearly up to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 1-year follow-up (yearly up to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 1-year follow-up (yearly up to 5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Quality of life (Efficacy)

Periprocedural complications (Safety)

Secondary study objectives

Left ventricular structure

Changes in Quality of life

Clinical safety endpoints

+11 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Invasive hemodynamic measurementsExperimental Treatment1 Intervention

Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording).

Group II: Doppler-echocardiographyExperimental Treatment1 Intervention

Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements.

0 / 3Eligibility 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 Stenosis (AVS) is commonly treated through surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). SAVR involves open-heart surgery to replace the narrowed valve with a prosthetic one, which improves blood flow and reduces symptoms. TAVR, including Valve-in-Valve TAVR (ViV-TAVR), is a less invasive procedure where a new valve is inserted via a catheter through the blood vessels to replace a failing bioprosthetic valve. This method is particularly beneficial for high-risk patients who may not tolerate open-heart surgery. These treatments are crucial as they alleviate the obstruction caused by the stenotic valve, thereby improving cardiac function and patient quality of life.