Balloon-expandable TAVI System for Aortic Stenosis
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.12345
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.12456
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the procedure with the Abbott BE TAVI system to treat severe aortic stenosis
Follow-up
Participants are monitored for device success and safety
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?
1
Treatment groups
Experimental Treatment
BE TAVI System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abbott Medical Devices
Lead Sponsor
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-dataNavitor 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.
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-studyThirty-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 ...
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-StenosisAbbott'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, ...
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 ...
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