New Aortic Heart Valves for Aortic Stenosis
Trial Summary
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.
Research Team
Vinny Podichetty
Principal Investigator
Abbott Structural Heart
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline assessments are conducted prior to the procedure
Procedure
Navitor Valve implantation via transfemoral or alternative access approach
Post-procedure Follow-up
Participants are monitored prior to hospital discharge and at 30 days for safety and effectiveness
Long-term Follow-up
Participants are followed up at 12 months and annually at 2, 3, 4, and 5 years
Treatment Details
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
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