Medtronic Evolut™ EXPAND TAVR I Feasibility Study
Status: Terminated
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm\^2, or aortic valve area index ≤ 0.6 cm\^2/m\^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec
• Subject denies symptoms attributable to aortic stenosis, including but not limited to:
‣ Dyspnea on rest or exertion
⁃ Angina
⁃ Syncope in the absence of another identifiable cause
⁃ Fatigue
⁃ Left Ventricular Ejection Fraction (LVEF) \>50%
Locations
United States
California
Los Robles Hospital & Medical Center
Thousand Oaks
New York
Northwell Health
Manhasset
Pennsylvania
UPMC Pinnacle Harrisburg Campus
Wormleysburg
Wisconsin
Aurora Saint Luke's Medical Center
Milwaukee
Other Locations
Australia
The Alfred Hospital
Melbourne
Canada
IUCPQ
Quebec
Israel
Rabin Medical Center
Petah Tikva
New Zealand
Waikato Hospital
Hamilton
Time Frame
Start Date: 2021-05-28
Completion Date: 2022-06-07
Participants
Target number of participants: 11
Treatments
Experimental: Medtronic Evolut™ PRO+ System
All study subjects will be treated with the Medtronic Evolut™ PRO+ TAVR System.
Authors
Tony Walton, Gregory Fontana, Tanvir Bajwa, Hemal Gada, Bruce Rutkin, Ran Kornowski, Josep Rodes-Cabau, Sanjeevan Pasupati
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiovascular