Navitor TAVI for Aortic Valve Stenosis
(ENVISION Trial)
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.12345
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.12345
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo Transcatheter Aortic Valve Implantation (TAVI) with either the Navitor system or any commercially available system
Follow-up
Participants are monitored for safety and effectiveness after the TAVI procedure
What Are the Treatments Tested in This Trial?
Interventions
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System
TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)
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
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.
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 ...
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 ...
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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structuralheart.abbott/products/transcatheter-aortic-valve-implantation/navitor-tavi-clinical-dataNavitor 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.
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