New Aortic Heart Valves for Aortic Stenosis

Recruiting at 30 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

333 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 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