Trial Outcomes & Findings for Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System (NCT NCT03102437)
NCT ID: NCT03102437
Last Updated: 2021-11-23
Results Overview
The FIX-HF-5CA Study was unofficially intended to serve as the Post-Approval Study (PAS) with the intention of collecting 3 year observed mortality data and comparing that to the predicted probability of mortality derived from two validated heart failure models \[MAGGIC (Meta-Analysis Global Group in Chronic Heart Failure) and SHFM (Seattle Heart Failure Model)\]. The objective was to show that the observed prevalence of mortality was not worse than the derived predicted probability of mortality. Upon PMA and PMA Supplement approval of the device, however, FDA and the Sponsor stopped this 5CA study and a new PAS was initiated (NCT03970343). No long-term mortality data or final analysis was collected for this study.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
2 years 6 months
Results posted on
2021-11-23
Participant Flow
Participant milestones
| Measure |
Optimizer Smart System (3-Lead)
All eligible subjects will have the Optimizer Smart System 3-Lead implanted and receive cardiac contractility modulation therapy (CCM).
Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Optimizer Smart System (2-Lead)
All eligible subjects will have the Optimizer Smart System 2-Lead implanted and receive cardiac contractility modulation therapy (CCM).
Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
36
|
|
Overall Study
COMPLETED
|
65
|
36
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System
Baseline characteristics by cohort
| Measure |
Optimizer Smart System (3-Lead)
n=70 Participants
All eligible subjects will have the Optimizer Smart System 3-Lead implanted and receive cardiac contractility modulation therapy (CCM).
Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Optimizer Smart System (2-Lead)
n=36 Participants
All eligible subjects will have the Optimizer Smart System 2-Lead implanted and receive cardiac contractility modulation therapy (CCM).
Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
66 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years 6 monthsPopulation: All subjects implanted with the Optimizer System.
The FIX-HF-5CA Study was unofficially intended to serve as the Post-Approval Study (PAS) with the intention of collecting 3 year observed mortality data and comparing that to the predicted probability of mortality derived from two validated heart failure models \[MAGGIC (Meta-Analysis Global Group in Chronic Heart Failure) and SHFM (Seattle Heart Failure Model)\]. The objective was to show that the observed prevalence of mortality was not worse than the derived predicted probability of mortality. Upon PMA and PMA Supplement approval of the device, however, FDA and the Sponsor stopped this 5CA study and a new PAS was initiated (NCT03970343). No long-term mortality data or final analysis was collected for this study.
Outcome measures
| Measure |
Optimizer Smart System (3-Lead)
n=70 Participants
All eligible subjects will have the Optimizer Smart System 3-Lead implanted and receive cardiac contractility modulation therapy (CCM).
Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Optimizer Smart System (2-Lead)
n=36 Participants
All eligible subjects will have the Optimizer Smart System 2-Lead implanted and receive cardiac contractility modulation therapy (CCM).
Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
|---|---|---|
|
Observed Mortality Comparison to the Predicted Probability of Mortality
|
5 Participants
|
0 Participants
|
Adverse Events
Optimizer Smart System (3-Lead)
Serious events: 13 serious events
Other events: 12 other events
Deaths: 5 deaths
Optimizer Smart System (2-Lead)
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Optimizer Smart System (3-Lead)
n=70 participants at risk
All eligible subjects will have the Optimizer Smart System 3-Lead implanted and receive cardiac contractility modulation therapy (CCM).
Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Optimizer Smart System (2-Lead)
n=36 participants at risk
All eligible subjects will have the Optimizer Smart System 2-Lead implanted and receive cardiac contractility modulation therapy (CCM).
Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
|---|---|---|
|
Surgical and medical procedures
Optimizer Lead dislodgement
|
2.9%
2/70 • Number of events 3 • 24 Months
|
5.6%
2/36 • Number of events 2 • 24 Months
|
|
Infections and infestations
Optimizer Pocket infection
|
1.4%
1/70 • Number of events 1 • 24 Months
|
0.00%
0/36 • 24 Months
|
|
Infections and infestations
Localized Infection
|
1.4%
1/70 • Number of events 1 • 24 Months
|
0.00%
0/36 • 24 Months
|
|
Cardiac disorders
ICD or pacemaker System AE
|
1.4%
1/70 • Number of events 1 • 24 Months
|
0.00%
0/36 • 24 Months
|
|
Cardiac disorders
Arrhythmias
|
2.9%
2/70 • Number of events 2 • 24 Months
|
0.00%
0/36 • 24 Months
|
|
General disorders
General Medical
|
2.9%
2/70 • Number of events 2 • 24 Months
|
0.00%
0/36 • 24 Months
|
|
Cardiac disorders
General Cardiopulmonary event
|
2.9%
2/70 • Number of events 2 • 24 Months
|
2.8%
1/36 • Number of events 1 • 24 Months
|
|
Nervous system disorders
Neurologic Dysfunction - TIA
|
1.4%
1/70 • Number of events 1 • 24 Months
|
2.8%
1/36 • Number of events 1 • 24 Months
|
|
Cardiac disorders
Worsening Heart Failure
|
2.9%
2/70 • Number of events 2 • 24 Months
|
0.00%
0/36 • 24 Months
|
Other adverse events
| Measure |
Optimizer Smart System (3-Lead)
n=70 participants at risk
All eligible subjects will have the Optimizer Smart System 3-Lead implanted and receive cardiac contractility modulation therapy (CCM).
Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
Optimizer Smart System (2-Lead)
n=36 participants at risk
All eligible subjects will have the Optimizer Smart System 2-Lead implanted and receive cardiac contractility modulation therapy (CCM).
Optimizer Smart System: The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
2.9%
2/70 • Number of events 2 • 24 Months
|
0.00%
0/36 • 24 Months
|
|
Cardiac disorders
General Cardiopulmonary Event
|
1.4%
1/70 • Number of events 1 • 24 Months
|
2.8%
1/36 • Number of events 1 • 24 Months
|
|
Blood and lymphatic system disorders
Thromboembolism (non-Neurologic)
|
1.4%
1/70 • Number of events 1 • 24 Months
|
0.00%
0/36 • 24 Months
|
|
Surgical and medical procedures
OPTIMIZER pocket stimulation
|
1.4%
1/70 • Number of events 1 • 24 Months
|
0.00%
0/36 • 24 Months
|
|
Surgical and medical procedures
ICD inappropriate therapy
|
0.00%
0/70 • 24 Months
|
2.8%
1/36 • Number of events 1 • 24 Months
|
|
General disorders
General Medical
|
11.4%
8/70 • Number of events 9 • 24 Months
|
2.8%
1/36 • Number of events 1 • 24 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Publication Committee shall consist of the National PIs and Impulse Dynamics representatives. All abstracts and papers of the multi-center publications will be reviewed by members of the publication committee and all authors. When appropriate, the publication committee will collect comments and resolve final draft issues. If a paper is rejected, the publication committee and its authors will decide the next course of action.
- Publication restrictions are in place
Restriction type: OTHER