Navitor TAVI for Aortic Valve Stenosis

(ENVISION Trial)

Enrolling by invitation at 86 trial locations

Overseen By Alicia Kimber

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Disqualifiers: Myocardial infarction, Coronary artery disease, Renal insufficiency, others

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

Compensation: Varies

Number of Visits: 1

Duration: Procedure day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for individuals with severe aortic stenosis, a condition where the heart valve doesn't open fully, leading to heart problems. The trial will also evaluate the Navitor TAVI System's performance in individuals whose previous heart valve replacements are failing and who cannot undergo another surgery. Ideal participants are those experiencing symptoms from aortic stenosis but are at a lower risk for surgical complications. As an unphased trial, this study offers participants the chance to contribute to significant research that could enhance future treatment options.

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 team or your doctor.

What prior data suggests that the Navitor TAVI System is safe for treating aortic stenosis?

Research has shown that the Navitor Transcatheter Aortic Valve Implantation (TAVI) System is generally safe for patients. In studies, 79.9% to 84.3% of patients experienced no major issues within the first 30 days after the procedure, indicating that most did well immediately following valve implantation. After one year, the Navitor valve continued to perform safely and effectively, supporting its use in patients at low to intermediate surgical risk. Additionally, studies found low rates of serious problems such as death and stroke, with no cases of moderate or severe leaks around the valve. These results suggest that the Navitor TAVI System is well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Navitor Transcatheter Aortic Valve Implantation (TAVI) System is unique because it offers a novel approach to treating aortic stenosis with potentially improved outcomes. Unlike other commercially available transcatheter aortic valve systems, Navitor is designed to minimize paravalvular leak, a common complication, by using a special sealing cuff. Additionally, its delivery system is designed for more precise valve placement, which can lead to better patient outcomes and increased durability of the implant. Researchers are excited about Navitor because it may offer enhanced safety and effectiveness over existing options for patients undergoing transcatheter aortic valve replacement.

What evidence suggests that the Navitor TAVI System is effective for treating aortic stenosis?

Research has shown that the Navitor Transcatheter Aortic Valve Implantation (TAVI) System, which participants in this trial may receive, is promising for treating severe aortic stenosis, a narrowing of the heart's aortic valve. One study found that the Navitor valve had a high success rate, with 97.7% of procedures completed successfully and 94.1% of devices functioning well. After 12 months, results were positive, supporting its use in patients with low or medium risk. Additionally, there were low rates of moderate or severe paravalvular leak (PVL), where blood leaks around the valve. These findings suggest that the Navitor TAVI System could be an effective treatment option for people with aortic stenosis. Another arm of this trial will use any commercially available Transcatheter Aortic Valve System (CAV) as a comparator. ^{1 2 3 4 5}

Who Is on the Research Team?

Barathi Sethuraman

Principal Investigator

Abbott Structural Heart

Michael Reardon, MD

Principal Investigator

The Methodist Hospital Research Institute

Azeem Azeem, MD

Principal Investigator

Montefiore Medical Center

Bassem Chehab, MD

Principal Investigator

Ascension Via Christi Hospitals Wichita, Inc.

Ibrahim Sultan, MD

Principal Investigator

The University of Pittsburgh Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

You are at an intermediate risk of overall surgical mortality, estimated to be between 3-8% within 30 days.

You have a low estimated risk of overall surgical mortality at 30 days, taking into account your STS Risk Score and NYHA Functional Classification

You have degenerative aortic valve stenosis, which is an obstruction that reduces the amount of blood flow through your heart's main artery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Transcatheter Aortic Valve Implantation (TAVI) with either the Navitor system or any commercially available system

Procedure day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the TAVI procedure

12 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Navitor Transcatheter Aortic Valve Implantation (TAVI) System

How Is the Trial Designed?

Group I: Navitor Transcatheter Aortic Valve Implantation (TAVI) System Experimental Treatment 1 Intervention

TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System

Group II: Any Commercially Available Transcatheter Aortic Valve System (CAV) Active Control 1 Intervention

TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)

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. jacc.org jacc.org/doi/10.1016/j.jcin.2025.08.021

30-Day and 1-Year Outcomes of Navitor Transcatheter ... The Navitor valve demonstrated favorable safety and performance outcomes at 12 months, supporting its expansion to low- and intermediate-risk populations.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936879825022034

Thirty-Day And One-Year Outcomes Of Navitor ... The Navitor transcatheter aortic valve is a self-expanding, intra-annular valve indicated for patients with severe aortic stenosis (AS) at high ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11910440/

Early clinical outcomes of transcatheter aortic valve ... Technical success was achieved in 31 (96.8%) patients, with a mean hospital stay of 10.8 ± 7.5 days. Although all patients successfully received ...

4. academic.oup.com academic.oup.com/eurheartj/article/46/Supplement_1/ehaf784.3206/8308572

30-Day Outcomes of the Navitor transcatheter aortic valve ... Technical and device success rates were achieved in 97.7% and 94.1% of cases, respectively. Early safety was reported in 79.9% of patients. At ...

5. structuralheart.abbott structuralheart.abbott/products/transcatheter-aortic-valve-implantation/navitor-tavi-clinical-data

Navitor TAVI Clinical Outcomes for Aortic Valve Implantation Explore the latest TAVI/TAVR clinical data for Navitor valves: 0% moderate or severe PVL, low mortality and stroke rates, and excellent hemodynamics.