What side effects are associated with this type of intervention?

Transcatheter aortic valve replacement (TAVR), including treatments like the Navitor (Portico™ NG) Transcatheter Aortic Heart Valve, commonly presents side effects such as bleeding, vascular complications, stroke, and paravalvular leak. Other potential risks include arrhythmias, kidney injury, and infection. These side effects are typically related to the procedure's invasiveness and the patient's overall health status.

What prior FDA approvals exist?

The FDA has approved several transcatheter aortic valve replacement (TAVR) devices for the treatment of aortic stenosis, which offer a minimally invasive alternative to traditional open-heart surgery. Notable approvals include the Edwards SAPIEN valve series and the Medtronic CoreValve system. These devices are designed to replace the diseased aortic valve via a catheter-based approach, significantly reducing recovery times and procedural risks for high-risk surgical patients. The Navitor (Portico™ NG) Transcatheter Aortic Heart Valve, currently under study, represents the next generation of these TAVR technologies, aiming to further improve safety and effectiveness.

What other types of research exist?

Promising novel alternatives to the Navitor (Portico™ NG) Transcatheter Aortic Heart Valve for aortic stenosis patients in 2024 include: 1) The Edwards SAPIEN 3 Ultra Resilia Valve, which offers enhanced durability and reduced calcification. 2) The Medtronic Evolut PRO+ TAVR System, known for its advanced sealing and ease of implantation. 3) The Boston Scientific ACURATE neo2 Valve System, which provides improved hemodynamic performance and reduced paravalvular leak. These alternatives are designed to improve patient outcomes through advanced materials and innovative design features.

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Heart Valve

New Aortic Heart Valves for Aortic Stenosis

N/A

Waitlist Available

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

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

Must have

Subject has symptomatic aortic stenosis as demonstrated by NYHA (New York Heart Association) Functional Classification of II, III, or IV

Subject has senile degenerative aortic valve stenosis with echo-derived criteria, defined as: aortic valve area (AVA) of ≤ 1.0 cm2 (or indexed EOA (effective orifice area) ≤ 0.6 cm2/m2) AND mean gradient ≥40 mmHg or peak jet velocity ≥ 4.0 m/s or doppler velocity index (DVI) ≤0.25. (Qualifying AVA baseline measurement must be within 90 days prior to informed consent)

Must not have

Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+)

Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new heart valve that can be inserted without open-heart surgery. It targets high-risk patients with severe aortic stenosis. The valve is put in through a small cut and helps the heart pump blood more effectively. This procedure offers an alternative to more invasive surgeries.

Who is the study for?

This trial is for high or extreme surgical risk patients with symptomatic aortic stenosis, confirmed by specific heart function classifications and measurements. Eligible participants must have an aortic valve area of ≤1.0 cm2 among other criteria, but cannot join if they've had recent heart attacks, certain blood disorders, previous heart valve replacements, or severe mitral valve issues.

What is being tested?

The study tests the safety and effectiveness of the Navitor (Portico™ NG) Transcatheter Aortic Heart Valve in reducing death rates at 30 days post-operation and minimizing paravalvular leaks in patients who are not good candidates for traditional surgery.

What are the potential side effects?

While not explicitly listed here, potential side effects may include bleeding due to anticoagulation therapy required after implantation, vascular complications from inserting the device through small vessels, stroke risks associated with heart procedures, and possible irregularities in heart rhythm.

Eligibility Criteria

Inclusion Criteria

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

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I have symptoms of aortic stenosis and my activity is somewhat to severely limited.

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My heart valve is severely narrowed, confirmed by an echo test within the last 3 months.

Exclusion Criteria

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

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My heart valve condition mainly involves severe leakage.

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I haven't had a stomach ulcer or upper GI bleeding in the last 3 months.

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I do not have severe blood disorders or a history of bleeding problems.

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I have a heart valve implant or severe heart valve issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 30 days

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

Treatment Details

Study Objectives

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

Primary study objectives

Primary Effectiveness Endpoint is Moderate or Greater Paravalvular Leak

Primary Safety Endpoint is All-cause Mortality

Secondary study objectives

Non-hierarchical Composite of All-cause Mortality, Disabling Stroke, Life Threatening Bleeding, Acute Kidney Injury (Stage 3), or Major Vascular Complications

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: Portico™ NG (Navitor) valve, FlexNav™ Delivery SystemExperimental Treatment1 Intervention

Portico ™ NG (Navitor) valve implantation with the new generation Portico NG (Navitor) valve (23mm, 25mm, 27mm and 29mm sizes), and the second-generation FlexNav Delivery system (small and large), Portico™ NG (Navitor) Loading System(s) (small and large).

Group II: Navitor Titan ValveExperimental Treatment1 Intervention

Navitor Titan Valve (35mm) implantation with the large FlexNav Delivery system and Navitor Loading System - LG+.

0 / 6Eligibility 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 Stenosis is commonly treated with Transcatheter Aortic Valve Replacement (TAVR), a minimally invasive procedure where a new valve is inserted via a catheter, typically through the femoral artery, to replace the diseased aortic valve. The mechanism of action involves expanding the new valve within the old, stenotic valve, which pushes the old valve leaflets aside and allows the new valve to take over the function of regulating blood flow from the heart to the aorta. This is significant for patients as it offers a less invasive alternative to open-heart surgery, reducing recovery time and associated risks, particularly in high or extreme surgical risk patients.