Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
Purpose
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%
Condition
- Heart Failure
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patient provides written authorization and/or consent per institution and geographical requirements 2. Male or non-pregnant female, aged 18 or older 3. Left ventricular ejection fraction of 25-45% (inclusive, per site assessment) 4. NYHA Class III heart failure symptoms 5. Stated willingness to comply with all study procedures and availability for the duration of the study 6. 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 2. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant 3. Myocardial infarction within 90 days prior to implant 4. Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant 5. Prior heart transplant or ventricular assist device 6. Mechanical tricuspid valve 7. 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 8. Participating in a cardiac investigational study at the same time 9. 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.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Other
- Time Perspective
- Prospective
Recruiting Locations
Mesa 5304391, Arizona 5551752 85206
Mesa 5304391, Arizona 5551752 85206
Mesa 5304391, Arizona 5551752 85206
Phoenix 5308655, Arizona 5551752 85006
Phoenix 5308655, Arizona 5551752 85006
Phoenix 5308655, Arizona 5551752 85016
Scottsdale 5313457, Arizona 5551752 85258
Tucson 5318313, Arizona 5551752 85712
Tucson 5318313, Arizona 5551752 85724
Chula Vista 5336899, California 5332921 91911
Fairfield 5347335, California 5332921 94533
Fresno 5350937, California 5332921 93720
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90048
Northridge 5377985, California 5332921 91325
Pasadena 5381396, California 5332921 91105
Torrance 5403022, California 5332921 90505
Aurora 5412347, Colorado 5417618 80012
Jacksonville 4160021, Florida 4155751 32216
Plantation 4168782, Florida 4155751 33324
Rome 4219762, Georgia 4197000 30165
Peoria 4905687, Illinois 4896861 61614
Rockford 4907959, Illinois 4896861 61107
Urbana 4914570, Illinois 4896861 61801
Indianapolis 4259418, Indiana 4921868 46237
Indianapolis 4259418, Indiana 4921868 46260
Lexington 4297983, Kentucky 6254925 40503
Lexington 4297983, Kentucky 6254925 40536
Boston 4930956, Massachusetts 6254926 02241
Novi 5004062, Michigan 5001836 38374
Southgate 5010646, Michigan 5001836 48195
Ypsilanti 5015688, Michigan 5001836 48197
Minneapolis 5037649, Minnesota 5037779 55407
Bridgeton 4378391, Missouri 4398678 63044
Kalispell 5660340, Montana 5667009 59901
Haddon Heights 4502093, New Jersey 5101760 08035
Marlton 4502911, New Jersey 5101760 08053
Morristown 5101427, New Jersey 5101760 07960
Newark 5101798, New Jersey 5101760 07719
Ridgewood 5103269, New Jersey 5101760 07450
New York 5128581, New York 5128638 10025
Asheville 4453066, North Carolina 4482348 28801
Charlotte 4460243, North Carolina 4482348 28204
Raleigh 4487042, North Carolina 4482348 27607
Cincinnati 4508722, Ohio 5165418 45242
Cleveland 5150529, Ohio 5165418 44106
Columbus 4509177, Ohio 5165418 43210
Steubenville 5173048, Ohio 5165418 43952
Toledo 5174035, Ohio 5165418 43608
Oklahoma City 4544349, Oklahoma 4544379 73120
Allentown 5178127, Pennsylvania 6254927 18104
Bryn Mawr 5182063, Pennsylvania 6254927 19010
Harrisburg 5192726, Pennsylvania 6254927 17011
Hershey 5193342, Pennsylvania 6254927 17033
Lancaster 5197079, Pennsylvania 6254927 17602
Philadelphia 4560349, Pennsylvania 6254927 19067
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19140
Philadelphia 4560349, Pennsylvania 6254927 19141
Pittsburgh 5206379, Pennsylvania 6254927 15212
Pittsburgh 5206379, Pennsylvania 6254927 15213
Reading 5207728, Pennsylvania 6254927 19611
Yardley 5220281, Pennsylvania 6254927 19067
Austin 4671654, Texas 4736286 78705
Dallas 4684888, Texas 4736286 75216
El Paso 5520993, Texas 4736286 79915
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
San Antonio 4726206, Texas 4736286 78229
Tyler 4738214, Texas 4736286 75702
Lynchburg 4771075, Virginia 6254928 24501
Midlothian 4772943, Virginia 6254928 23114
Richmond 4781708, Virginia 6254928 23225
Richmond 4781708, Virginia 6254928 23249
Huntington 4809537, West Virginia 4826850 25701
Milwaukee 5263045, Wisconsin 5279468 53215
More Details
- NCT ID
- NCT03970343
- Status
- Recruiting
- Sponsor
- Impulse Dynamics
Detailed 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.