A Prospective, Multi-center, Non-randomized, Single Arm Open Label Study of 620 Subjects Receiving the OPTIMIZER Smart With CCM Therapy as Standard of Care
Status: Recruiting
Location: See all (62) locations...
Intervention Type: Device
Study Type: Observational [Patient Registry]
SUMMARY
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45%
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:
• Patient provides written authorization and/or consent per institution and geographical requirements
• Male or non-pregnant female, aged 18 or older
• Left ventricular ejection fraction of 25-45% (inclusive)
• NYHA Class III heart failure symptoms
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Patient has been treated with guideline-directed medical therapy
Locations
United States
Arizona
CardioVascular Associates of Mesa (CVAM)
Recruiting
Mesa
Chan Heart Rhythm Institute (CHRI)
Recruiting
Mesa
Southwest Cardiovascular Associates
Recruiting
Mesa
Honor Health
Recruiting
Scottsdale
Pima Heart & Vascular
Recruiting
Tucson
University of AZ - Sarver Heart Center
Recruiting
Tucson
California
Cardiovascular Institute of San Diego
Recruiting
Chula Vista
Mid Valley Cardiology - Fresno
Recruiting
Fresno
University of Southern California - Keck School of Medicine
Recruiting
Los Angeles
Torrance Memorial Medical Center
Recruiting
Torrance
Washington, D.c.
MedStar Washington Hospital Center
Not yet recruiting
Washington
Florida
Naples Heart Rhythm Specialists
Not yet recruiting
Naples
Florida Cardiology
Recruiting
Orlando
Georgia
Piedmont Heart
Recruiting
Atlanta
Redmond Regional Medical Center
Recruiting
Rome
Illinois
Advocate Illinois Masonic Medical Center
Completed
Chicago
Advocate Good Samaritan Hospital
Completed
Downers Grove
Kentucky
Baptist Lexington
Recruiting
Lexington
University of Kentucky - Gill Heart & Vascular Institute Clinical Research
Recruiting
Lexington
Michigan
Ascension St. John Hospital
Not yet recruiting
Detroit
Sparrow Clinical Research Institute
Recruiting
Lansing
St. Joseph Mercy Oakland
Recruiting
Pontiac
Downriver Heart and Vascular
Recruiting
Southgate
Missouri
St. Louis Heart and Vascular
Recruiting
Bridgeton
North Carolina
Mission Health
Recruiting
Asheville
Atrium Health
Recruiting
Charlotte
NC Heart and Vascular Research
Recruiting
Raleigh
New Jersey
Cooper Hospital
Recruiting
Haddon Heights
Virtua Health - Our Lady of Lourdes
Recruiting
Marlton
Morristown Medical Center
Recruiting
Morristown
Jersey Shore University Medical Center
Recruiting
Neptune
Rutgers Medical School
Recruiting
Newark
The Valley Hospital
Recruiting
Ridgewood
New York
Mount Sinai Morningside
Recruiting
New York
Ohio
TriHealth Hatton
Recruiting
Cincinnati
University Hospitals of Cleveland Medical Center
Recruiting
Cleveland
Ohio State University
Recruiting
Columbus
Regional Cardiac Arrythmia Inc.
Recruiting
Steubenville
Mercy Health - St. Vincent Medical Center
Recruiting
Toledo
ProMedica Health Systems
Recruiting
Toledo
Oklahoma
Oklahoma Heart Hospital
Recruiting
Oklahoma City
Pennsylvania
St. Luke's University Health Network
Recruiting
Allentown
Bryn Mawr Hospital
Recruiting
Bryn Mawr
UPMC Pinnacle Health
Recruiting
Harrisburg
Penn State Milton S. Hershey Medical Center
Recruiting
Hershey
Penn Medicine Lancaster General Hospital
Recruiting
Lancaster
Albert Einstein Medical Center
Recruiting
Philadelphia
Cardiology Consultants of Philadelphia
Recruiting
Philadelphia
Hospital of the University of Pennsylvania
Completed
Philadelphia
Penn Presybyterian Medical Center
Recruiting
Philadelphia
Temple University Hospital
Recruiting
Philadelphia
Allegheny General Hospital
Recruiting
Pittsburgh
UPMC Heart and Vascular Institute
Recruiting
Pittsburgh
Reading Hospital
Recruiting
Reading
Texas
Texas Cardiac Arrhythmia Research
Recruiting
Austin
VA North Texas Medical Center
Recruiting
Dallas
Baylor College of Medicine
Recruiting
Houston
CHRISTUS Trinity Clinic Research
Recruiting
Tyler
Virginia
HCA Chippenham Hospital
Recruiting
Richmond
Wisconsin
Aurora Research Institute
Recruiting
Milwaukee
West Virginia
CAMC Clinical Trials Center
Completed
Charleston
Marshall Cardiology
Recruiting
Huntington
Contact Information
Primary
Mitchel Lustre
mlustre@impulsedynamics.com
718-869-2420
Time Frame
Start Date: January 21, 2020
Estimated Completion Date: March 1, 2026
Participants
Target number of participants: 620
Authors
Toshimasa Okabe, Maninder Bedi, Gery Tomassoni, Sheetal Chandhok, Alfonso Waller, Sandeep Jain, Joyce Wald, Rafiq Ramadan, David Scollan, Erol Kosar, Matthew Bernabei, Michael Hoosien, Ranjit Suri, Dilesh Patel, Aaref Badshah, Usman Siddiqui, Johan Aasbo, John Rhyner, Thomas Mattioni, Mark Mascarenhas, Jodi Zilinski, Sumeet Mainigi, Steven Carlson, Suneet Mittal, Steven Levi, Phi Wiegn, Jared Green, Darren Peress, Sohail Hassan, Charles Te, Ivan Cakulev, Carlos Rueda, Chafik Assal, Timothy Phelan, Michael L Krueger, Ambrose Panico, Sameh Mobarek, Edo Birati, Craig McCotter, Darius Sholevar, Rodrigo Chan, Richard Borge, Rohit Mehta, Isaac Whitman, Heath Saltzman, Andrew Wickliffe, Peter Brady, Rajiv Nair, Andrew Yin, Mathew Hutchinson, Howard Eisen, Aaron Hesselson, Matthew Sandler, Qaiser Shafiq, Mohammad Mortada, Andrew Zadeh, Burhan Mohamedali, Ali Valika, Paul Okhumale, Abhishek Singh, Mihail Chelu, Guru Mohanty, John Sims, Kenneth Plunkitt, Charles Jost, David Strouse, Christopher Schulze, Mark Richards, Mohamed Hani, Anju Basil, Karen Ellison, Roberto Hodara, Steve Stevens, Imran Niazi, Emad Aziz, George Mark, Ajay Vallakati, Benjamin D'Souza, Ameer Kabour, Stan Weiner, Andrew Kaplan, Robert Styperek, Robert Canby
Related Therapeutic Areas
Sponsors
Leads: Impulse Dynamics