Portico Next Generation Approval Study
AI Description
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the rate of moderate or greater paravalvular leak at 30 days in a high or extreme surgical risk patient population to support CE (Conformité Européenne) Mark and FDA approval.
- Who can join
- adult, older adult
- Participants
- 333
- Expected completion
- 2033-01
- Funded by
- industry
Conditions studied
Symptomatic Severe Aortic Stenosis
What is being tested
- DEVICE: Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- DEVICE: Portico™ NG (Navitor) Valve and FlexNav™ Delivery System
What it measures
- Primary Effectiveness Endpoint is Moderate or Greater Paravalvular Leak, Number of participants with moderate or greater paravalvular leak at 30 days., at 30 days
- Primary Safety Endpoint is All-cause Mortality, All-cause mortality is defined as the total number of deaths in each cohort at 30 days., at 30 days
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Abbott Northwestern Hospital
Minneapolis, MN
Advocate Christ Medical Center (Oak Lawn)
Oak Lawn, IL
Albany Medical Center
Albany, NY
Ascension St. Vincent Heart Center
Carmel, IN
Ascension Via Christi (Wichita)
Wichita, KS
Baptist Memorial Hospital-Memphis
Memphis, TN
Baylor Scott & White The Heart Hospital – Plano
Plano, TX
Cedars-Sinai Medical Center
Los Angeles, CA
Houston Methodist Hospital
Houston, TX
Intermountain St. George Regional Hospital
St George, UT
Los Robles Regional Medical Center
Thousand Oaks, CA
MedStar Washington Hospital Center
Washington, DC
Mission Hospital (Asheville)
Asheville, NC
Montefiore Einstein Hospital (Moses Campus)
Bronx, NY
Morristown Medical Center
Morristown, NJ
Providence St. Vincent Medical Center
Portland, OR
Sentara Norfolk General Hospital
Norfolk, VA
UM Health-Sparrow (Lansing)
Lansing, MI
University Hospitals Cleveland Medical Center
Cleveland, OH
UPMC Presbyterian Shadyside
Pittsburgh, PA
Registry entry updated 2026-07-21
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.