AltaValve Early Feasibility Study Protocol
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subjects ≥ 18 years of age.
• Subjects symptomatic New York Heart Association (NYHA) II-IV.
• Subjects with severe MR as documented by echo.
• Subjects who are at high risk for open-heart surgery as documented by the health care professional (e.g., Heart Team consisting of cardiac surgeon and interventional cardiologist in United States).
Locations
United States
Arizona
Tucson Medical Center
RECRUITING
Tucson
California
Los Robles Regional Medical Center
RECRUITING
Thousand Oaks
Washington, D.c.
MedStar Washington Hospital
RECRUITING
Washington
Florida
Tampa General Hospital
RECRUITING
Tampa
Georgia
Emory University
RECRUITING
Atlanta
Louisiana
Cardiovascular Institute of the South
RECRUITING
Houma
North Carolina
Atrium Health
RECRUITING
Charlotte
New Jersey
Morristown Medical Center
RECRUITING
Morristown
Oklahoma
Oklahoma Heart Hospital
RECRUITING
Oklahoma City
Tennessee
Baptist Memorial Hospital - Memphis
RECRUITING
Memphis
Texas
Houston Methodist Hospital
RECRUITING
Houston
Baylor Scott & White
RECRUITING
Plano
Contact Information
Primary
Adam Lawrence
AltaValveEFS@4CMed.com
+1-727-318-2203
Time Frame
Start Date: 2019-12-04
Estimated Completion Date: 2025-09
Participants
Target number of participants: 15
Authors
Moritz Wyler von Ballmoos, Peter Fail, Sachin Goel, Tsuyoshi Kaneko, Curtis Anderson, Daren Danielson, Pinak Shah, Thom Dahle, Michael Rinaldi, Willis Wu, Jeffrey Christy, Nilesh Goswami, George A Petrossian, Stephen Ball, James Slater, Satya Shreenivas, Ron Waksman, Newell B Robinson, Joseph Choo, Francois Dagenais, Kenichiro Noguchi, Josep Rodes-Cabau, Shigeru Saito, Michel Pellerin, Anita Asgar
Related Therapeutic Areas
Sponsors
Leads: 4C Medical Technologies, Inc.