Balloon-expandable TAVI System for Aortic Stenosis

Recruiting at 3 trial locations

Overseen By Nadia Bouhdi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Disqualifiers: Pregnancy, Life expectancy <2 years, others

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

Compensation: Varies

Number of Visits: 1

Duration: Procedure duration

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart valve treatment called the BE TAVI system (Balloon-expandable Transcatheter Aortic Valve Implantation system). It targets individuals with severe aortic stenosis, a condition where the heart valve doesn't open properly, hindering the heart's ability to pump blood. The study aims to determine the safety and effectiveness of this new treatment. Individuals diagnosed with this specific heart condition and experiencing symptoms might be suitable candidates. As an unphased trial, it offers patients the chance to contribute to groundbreaking research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

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 the BE TAVI System is safe for treating aortic stenosis?

Research has shown that the Abbott BE TAVI System is generally safe for individuals with aortic stenosis, a condition where the heart valve narrows. Studies on the Navitor TAVI system, a similar technology, have demonstrated positive outcomes. Specifically, after 30 days, about 80% of patients experienced early safety, and the procedure succeeded in nearly 98% of cases. After one year, the rates of issues such as stroke or severe valve leaks remained low. This evidence suggests that the Abbott BE TAVI System is well-tolerated, with a low risk of serious complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Abbott BE TAVI System is unique because it offers a less invasive alternative for treating aortic stenosis, a condition where the heart's aortic valve narrows, making it hard for blood to flow. Traditional treatments often involve open-heart surgery, which can be risky and require a long recovery time. This system, however, uses a balloon-expandable valve that can be inserted via a catheter, meaning less trauma and faster recovery for patients. Researchers are excited because this approach could make treatment accessible to those who aren’t good candidates for surgery, offering a safer, quicker option with potentially similar outcomes.

What evidence suggests that the Abbott BE TAVI System is effective for aortic stenosis?

Research has shown that the Abbott BE TAVI System, which participants in this trial will receive, effectively treats severe aortic stenosis, a condition where the heart's aortic valve narrows. Studies have found that the Navitor valve, part of this system, performs well, with no moderate or severe leaks around the valve and low rates of death and stroke. After 12 months, patients using this system demonstrated good safety and performance results, even those at high risk for surgery. Additionally, the system succeeded in 96.8% of early patient cases. These findings support its use for people with severe aortic stenosis. ^{1 2 4 5 6}

Who Is on the Research Team?

Ashish Oza

Principal Investigator

Abbott Structural Heart

Are You a Good Fit for This Trial?

This trial is for patients with severe, symptomatic aortic stenosis—a condition where the heart's aortic valve narrows. Participants should have symptoms like chest pain, fainting, or shortness of breath due to this condition.

Inclusion Criteria

I can and will come back for all needed follow-up visits.

My heart valve is severely narrowed, confirmed by an echo test.

I am 18 years old or older.

Exclusion Criteria

Pregnant or nursing subjects

My liver is not working properly.

I am not able to make decisions for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the procedure with the Abbott BE TAVI system to treat severe aortic stenosis

Procedure duration

1 visit (in-person)

Follow-up

Participants are monitored for device success and safety

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Abbott BE TAVI System

Trial Overview The study is testing Abbott's Balloon-expandable (BE) TAVI System. It aims to assess how safe and effective this system is in treating patients with severe aortic stenosis.

How Is the Trial Designed?

Group I: BE TAVI System Experimental Treatment 1 Intervention

BE TAVI System

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. 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 clinical data for Navitor valves: 0% moderate or severe PVL, low mortality and stroke rates, and excellent hemodynamics.

2. 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.

3. eurointervention.pcronline.com eurointervention.pcronline.com/article/thirty-day-and-one-year-outcomes-of-the-navitor-transcatheter-heart-valve-in-patients-with-aortic-stenosis-the-prospective-multicentre-global-portico-ng-study

Thirty-day and one-year outcomes of the Navitor ... Conclusions: The PORTICO NG Study demonstrates low rates of adverse events and PVL up to 1 year in patients at high or extreme surgical risk, confirming the ...

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

Early clinical outcomes of transcatheter aortic valve ... Among 32 consecutive patients (mean age, 84 years; 19% female), technical success was achieved in 31 (96.8%). One patient developed a subclavian ...

5. abbott.mediaroom.com abbott.mediaroom.com/2025-08-29-Abbotts-Navitor-TM-TAVI-System-Receives-CE-Mark-for-Expanded-Indication-to-Treat-More-People-With-Aortic-Stenosis

Abbott's Navitor™ TAVI System Receives CE Mark for ... The late-breaking data presented at ESC from Abbott's VANTAGE study showed Navitor met all safety and effectiveness primary endpoints, ...

6. 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 ...