New Aortic Heart Valves for Aortic Stenosis

Not currently recruiting at 32 trial locations

Overseen By Sara Scrivano

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Disqualifiers: Myocardial infarction, Stroke, Blood dyscrasias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new aortic heart valves designed to treat aortic stenosis, a condition where the heart's aortic valve narrows, hindering blood flow. Researchers aim to assess the safety and effectiveness of these valves by monitoring for any deaths or leaks around the valve 30 days after implantation. The trial evaluates two types of valves: the Navitor Titan Valve (35mm) and the Portico NG Valve, each with distinct sizes and delivery systems. Individuals who have experienced symptoms of aortic stenosis for an extended period and are considered high-risk for surgery may be suitable candidates for this trial. As an unphased trial, it offers patients access to innovative treatments that could improve their condition.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these heart valves and delivery systems are safe for patients with aortic stenosis?

A previous study found the Navitor Titan Valve to be safe, with fewer cases of severe bleeding and major blood vessel problems compared to other treatments. Another study confirmed its safety and effectiveness for patients at high surgical risk.

Research shows the Portico NG (Navitor) Valve also has low rates of serious issues up to one year after treatment, indicating few major problems reported post-use. It has proven safe for individuals with severe aortic stenosis, a heart valve condition. Both valves have been tested in high-risk surgical patients, demonstrating they are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the new aortic heart valves for aortic stenosis because they offer innovative advancements in how these valves are delivered and function. The Navitor Titan Valve, for instance, uses a large 35mm size combined with the Large FlexNav™ Delivery System, potentially improving the ease and precision of valve implantation. This is a step forward from traditional surgical options, which often require more invasive procedures. Additionally, the Portico™ NG (Navitor) valve uses a new generation design with multiple sizes and a second-generation FlexNav Delivery system, which could enhance patient outcomes by allowing for more tailored and less invasive valve replacement. These features aim to improve both the safety and effectiveness of treating aortic stenosis compared to existing surgical and transcatheter methods.

What evidence suggests that these heart valves are effective for aortic stenosis?

Research has shown that the Navitor valve, which participants in this trial may receive, is safe and effective for treating severe narrowing of the heart's aortic valve in patients at high surgical risk. One study found low rates of complications and blood leakage around the valve up to one year after placement. Another study reported fewer cases of severe bleeding and major blood vessel issues with the Navitor system. Additionally, the Navitor Titan valve, another option in this trial, is designed for patients with larger aortic valve openings and has shown promise in these cases. Overall, evidence supports the effectiveness of the Navitor heart valves in high-risk patients with aortic valve narrowing. ^{1 2 3 5 6}

Who Is on the Research Team?

Vinny Podichetty

Principal Investigator

Abbott Structural Heart

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

Your aortic annulus and ascending aorta are within a certain size range as measured by a CT scan for the specified valve size.

Exclusion Criteria

You had a heart attack with ST segment elevation on an ECG within the past 30 days.

I had a heart or blood vessel procedure through the skin within the last 30 days.

I have had a stroke or a mini-stroke in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Baseline assessments are conducted prior to the procedure

1 week

1 visit (in-person)

Procedure

Navitor Valve implantation via transfemoral or alternative access approach

1 day

1 visit (in-person)

Post-procedure Follow-up

Participants are monitored prior to hospital discharge and at 30 days for safety and effectiveness

30 days

2 visits (in-person)

Long-term Follow-up

Participants are followed up at 12 months and annually at 2, 3, 4, and 5 years

5 years

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
• Portico™ NG (Navitor) Valve and FlexNav™ Delivery System
• Portico™ NG Valve and FlexNav™ Delivery System

Trial Overview 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.

How Is the Trial Designed?

Group I: Portico™ NG (Navitor) valve, FlexNav™ Delivery System Experimental Treatment 1 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 Valve Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11239129/

A Comprehensive Evaluation of the NAVITOR ... Additionally, the Navitor™ system exhibited lower rates of severe bleeding (27.3% versus 13.1%) and major vascular complications (5.8% versus ...

2. jacc.org jacc.org/doi/10.1016/j.jcin.2023.02.002

The International PORTICO NG Study The Navitor valve is safe and effective for the treatment of subjects with severe aortic stenosis who are at high or greater risk for surgery.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155383892200166X

TAVR With the Novel Navitor Titan™ Transcatheter Heart ... The Navitor Titan™ transcatheter heart valve has been developed to treat patients with large aortic annuli, namely aortic annulus perimeter 85 to 95 mm.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04788888

Evaluation of TAVR Using the NAVITOR Valve in a Global ... The VANTAGE clinical trial will evaluate the safety and effectiveness of the Navitor valve in patients with severe, symptomatic aortic stenosis who are at ...

5. structuralheart.abbott structuralheart.abbott/fileadmin/pdf/25-109424_Clinical_Insights_regarding_Real_World_Experience_with_the_Navitor_Valve_in_US_Patients.pdf

10.6% New PPI With Navitor™ Vision* Valve After 20 ... KEY POINTS. • Increased device experience is associated with a significant reduction in permanent pacemaker implantation (PPI) at 30 days.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40892604/

Thirty-Day And One-Year Outcomes Of Navitor ... Conclusion: Navitor demonstrated favorable safety and performance outcomes at 12 months, supporting its expansion to low- and intermediate-risk ...