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Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy

Sponsor
Impulse Dynamics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03970343
Collaborator
(none)
620
Enrollment
56
Locations
73.3
Anticipated Duration (Months)
11.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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%

Condition or Disease Intervention/Treatment Phase
  • Device: OPTIMIZER Smart System

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
620 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Jan 21, 2020
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Incidence of procedure and device-related complications [1 year]

    Demonstrate, in the post-approval setting, that the OPTIMIZER Smart is safe to use, by assessing the rate of procedure related complications (30 days) and device related complications (1-year)

  2. All-cause mortality [3 years]

    Observed mortality will be compared to the predicted mortality according to the Seattle Heart Failure Model (SHFM) at 1 year and 3 years post-implant

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. 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)

  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:

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CardioVascular Associates of Mesa (CVAM) Mesa Arizona United States 85206
2 Chan Heart Rhythm Institute (CHRI) Mesa Arizona United States 85206
3 Southwest Cardiovascular Associates Mesa Arizona United States 85206
4 Honor Health Scottsdale Arizona United States 85258
5 University of AZ - Sarver Heart Center Tucson Arizona United States 85724
6 Cardiovascular Institute of San Diego Chula Vista California United States 91911
7 Mid Valley Cardiology - Fresno Fresno California United States 93720
8 Torrance Memorial Medical Center Torrance California United States 90505
9 MedStar Washington Hospital Center Washington District of Columbia United States 20010
10 Naples Heart Rhythm Specialists Naples Florida United States 34119
11 Florida Cardiology Orlando Florida United States 32792
12 Piedmont Heart Atlanta Georgia United States 30309
13 Redmond Regional Medical Center Rome Georgia United States 30165
14 Advocate Illinois Masonic Medical Center Chicago Illinois United States 60657
15 Advocate Good Samaritan Hospital Downers Grove Illinois United States 60515
16 Baptist Lexington Lexington Kentucky United States 40503
17 University of Kentucky - Gill Heart & Vascular Institute Clinical Research Lexington Kentucky United States 40536
18 Ascension St. John Hospital Detroit Michigan United States 48236
19 St. Joseph Mercy Oakland Pontiac Michigan United States 48341
20 Cooper Hospital Haddon Heights New Jersey United States 08035
21 Virtua Health - Our Lady of Lourdes Marlton New Jersey United States 08053
22 Morristown Medical Center Morristown New Jersey United States 07960
23 Jersey Shore University Medical Center Neptune New Jersey United States 07753
24 Rutgers Medical School Newark New Jersey United States 07719
25 The Valley Hospital Ridgewood New Jersey United States 07450
26 Mount Sinai Morningside New York New York United States 10025
27 Mission Health Asheville North Carolina United States 28801
28 Atrium Health Charlotte North Carolina United States 28204
29 NC Heart and Vascular Research Raleigh North Carolina United States 27607
30 TriHealth Hatton Cincinnati Ohio United States 45242
31 University Hospitals of Cleveland Medical Center Cleveland Ohio United States 44106
32 Ohio State University Columbus Ohio United States 43210
33 Regional Cardiac Arrythmia Inc. Steubenville Ohio United States 43952
34 ProMedica Health Systems Toledo Ohio United States 43606
35 Mercy Health - St. Vincent Medical Center Toledo Ohio United States 43608
36 St. Luke's University Health Network Allentown Pennsylvania United States 18104
37 Bryn Mawr Hospital Bryn Mawr Pennsylvania United States 19010
38 UPMC Pinnacle Health Harrisburg Pennsylvania United States 17011
39 Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
40 Penn Medicine Lancaster General Hospital Lancaster Pennsylvania United States 17602
41 Cardiology Consultants of Philadelphia Philadelphia Pennsylvania United States 19067
42 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
43 Penn Presybyterian Medical Center Philadelphia Pennsylvania United States 19104
44 Temple University Hospital Philadelphia Pennsylvania United States 19140
45 Albert Einstein Medical Center Philadelphia Pennsylvania United States 19141
46 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
47 UPMC Heart and Vascular Institute Pittsburgh Pennsylvania United States 15213
48 Reading Hospital Reading Pennsylvania United States 19611
49 Texas Cardiac Arrhythmia Research Austin Texas United States 78705
50 VA North Texas Medical Center Dallas Texas United States 75216
51 Baylor College of Medicine Houston Texas United States 77030
52 CHRISTUS Trinity Clinic Research Tyler Texas United States 75702
53 HCA Chippenham Hospital Richmond Virginia United States 23225
54 CAMC Clinical Trials Center Charleston West Virginia United States 25304
55 Marshall Cardiology Huntington West Virginia United States 25701
56 Aurora Research Institute Milwaukee Wisconsin United States 53215

Sponsors and Collaborators

  • Impulse Dynamics

Investigators

  • Study Director: Rami Kahwash, MD, The Ohio State University Wexner Medical Center
  • Study Director: Raul Weiss, MD, The Ohio State University Wexner Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Impulse Dynamics
ClinicalTrials.gov Identifier:
NCT03970343
Other Study ID Numbers:
  • CA_CP_307
First Posted:
May 31, 2019
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Impulse Dynamics
OPTIMIZER
Heart Failure
CCM
Post-Approval Study
NYHA class III
FIX-HF-5C
Chronic heart failure
Ejection fraction between 25 and 45
cardiac contractility modulation
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Jun 30, 2022