Heart Failure Clinical Trial
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
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%
Full Description
The Impulse Dynamics OPTIMIZER Smart Pre-Market Application (PMA) clinical data confirmed that CCM therapy delivered with the Optimizer meaningfully improved health outcomes in patients with NYHA class III heart failure symptoms and left ventricular ejection fraction of 25-45%. CCM has shown significant improvements in quality of life measures, with an average improvement of >11 points in MLHWFQ incremental to the improvement of a randomized control group with no device. Six minute hall walk and functional class also showed improvements in the PMA data. The post-approval study (PAS) protocol has been designed to evaluate long term safety and efficacy of the OPTIMIZER Smart in a real-world setting.
Eligibility Criteria
Inclusion Criteria:
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, per site assessment)
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
Exclusion Criteria:
Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
Myocardial infarction within 90 days prior to implant
Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
Prior heart transplant or ventricular assist device
Mechanical tricuspid valve
Receiving cardiac resynchronization therapy (CRT) or has a Class I indication for CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy
Participating in a cardiac investigational study at the same time
Patient is in a vulnerable population (such as significant mental disability, prisoner) that in the judgement of the PI impedes ability to provide informed consent.
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There are 75 Locations for this study
Mesa Arizona, 85206, United States More Info
Principal Investigator
Mesa Arizona, 85206, United States More Info
Principal Investigator
Mesa Arizona, 85206, United States More Info
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Phoenix Arizona, 85006, United States More Info
Principal Investigator
Phoenix Arizona, 85006, United States More Info
Principal Investigator
Phoenix Arizona, 85016, United States More Info
Principal Investigator
Scottsdale Arizona, 85258, United States More Info
Principal Investigator
Tucson Arizona, 85712, United States More Info
Principal Investigator
Tucson Arizona, 85719, United States More Info
Principal Investigator
Tucson Arizona, 85724, United States More Info
Principal Investigator
Chula Vista California, 91911, United States More Info
Principal Investigator
Sub-Investigator
Fairfield California, 94533, United States More Info
Principal Investigator
Fresno California, 93720, United States More Info
Principal Investigator
Los Angeles California, 90033, United States More Info
Principal Investigator
Los Angeles California, 90048, United States More Info
Principal Investigator
Northridge California, 91325, United States More Info
Principal Investigator
Pasadena California, 91105, United States More Info
Principal Investigator
Torrance California, 90505, United States More Info
Principal Investigator
Aurora Colorado, 80012, United States More Info
Principal Investigator
Washington District of Columbia, 20010, United States More Info
Principal Investigator
Davie Florida, 33328, United States More Info
Principal Investigator
Jacksonville Florida, 32216, United States More Info
Principal Investigator
Naples Florida, 34119, United States More Info
Principal Investigator
Sub-Investigator
Orlando Florida, 32792, United States More Info
Principal Investigator
Atlanta Georgia, 30309, United States
Rome Georgia, 30165, United States More Info
Principal Investigator
Chicago Illinois, 60657, United States
Downers Grove Illinois, 60515, United States
Lexington Kentucky, 40503, United States More Info
Principal Investigator
Sub-Investigator
Sub-Investigator
Lexington Kentucky, 40536, United States More Info
Principal Investigator
Sub-Investigator
Novi Michigan, 38374, United States More Info
Principal Investigator
Pontiac Michigan, 48341, United States More Info
Principal Investigator
Sub-Investigator
Southgate Michigan, 48195, United States More Info
Principal Investigator
Minneapolis Minnesota, 55407, United States More Info
Principal Investigator
Bridgeton Missouri, 63044, United States More Info
Principal Investigator
Haddon Heights New Jersey, 08035, United States More Info
Principal Investigator
Marlton New Jersey, 08053, United States More Info
Principal Investigator
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Sub-Investigator
Sub-Investigator
Morristown New Jersey, 07960, United States More Info
Principal Investigator
Neptune New Jersey, 07753, United States More Info
Principal Investigator
Newark New Jersey, 07719, United States More Info
Principal Investigator
Sub-Investigator
Ridgewood New Jersey, 07450, United States More Info
Principal Investigator
New York New York, 10025, United States More Info
Principal Investigator
Asheville North Carolina, 28801, United States More Info
Principal Investigator
Charlotte North Carolina, 28204, United States More Info
Principal Investigator
Raleigh North Carolina, 27607, United States More Info
Principal Investigator
Cincinnati Ohio, 45242, United States More Info
Principal Investigator
Cleveland Ohio, 44106, United States More Info
Principal Investigator
Columbus Ohio, 43210, United States More Info
Principal Investigator
Columbus Ohio, 43213, United States More Info
Principal Investigator
Steubenville Ohio, 43952, United States More Info
Principal Investigator
Toledo Ohio, 43606, United States More Info
Contact
Principal Investigator
Toledo Ohio, 43608, United States More Info
Principal Investigator
Oklahoma City Oklahoma, 73120, United States More Info
Principal Investigator
Allentown Pennsylvania, 18104, United States More Info
Principal Investigator
Bryn Mawr Pennsylvania, 19010, United States More Info
Principal Investigator
Harrisburg Pennsylvania, 17011, United States More Info
Principal Investigator
Hershey Pennsylvania, 17033, United States More Info
Principal Investigator
Lancaster Pennsylvania, 17602, United States More Info
Principal Investigator
Philadelphia Pennsylvania, 19067, United States More Info
Principal Investigator
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19104, United States More Info
Principal Investigator
Philadelphia Pennsylvania, 19140, United States More Info
Principal Investigator
Sub-Investigator
Philadelphia Pennsylvania, 19141, United States More Info
Principal Investigator
Pittsburgh Pennsylvania, 15212, United States More Info
Principal Investigator
Pittsburgh Pennsylvania, 15213, United States More Info
Principal Investigator
Reading Pennsylvania, 19611, United States More Info
Principal Investigator
Reading Pennsylvania, 19611, United States More Info
Principal Investigator
Sub-Investigator
Yardley Pennsylvania, 19067, United States More Info
Principal Investigator
Austin Texas, 78705, United States More Info
Principal Investigator
Dallas Texas, 75216, United States More Info
Principal Investigator
El Paso Texas, 79915, United States More Info
Principal Investigator
Houston Texas, 77030, United States More Info
Principal Investigator
Houston Texas, 77030, United States More Info
Principal Investigator
San Antonio Texas, 78229, United States More Info
Principal Investigator
Tyler Texas, 75702, United States More Info
Principal Investigator
Sub-Investigator
Lynchburg Virginia, 24501, United States More Info
Principal Investigator
Midlothian Virginia, 23114, United States More Info
Principal Investigator
Richmond Virginia, 23225, United States More Info
Principal Investigator
Charleston West Virginia, 25304, United States
Huntington West Virginia, 25701, United States More Info
Principal Investigator
Sub-Investigator
Milwaukee Wisconsin, 53215, United States More Info
Principal Investigator
Sub-Investigator
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Sub-Investigator
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