Heart FailureFIX-HF-5CANCT03102437
Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System
A study testing Optimizer Smart System in people with Heart Failure and Congestive Heart Failure, run by Impulse Dynamics at 17 sites in United States.
Trial summary
This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive Heart Failure, Chronic Heart Disease
- What is being tested?
- Optimizer Smart System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 17 sitesUnited States
- Study dates
- 1 Jul 2017to 16 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are 18 years of age or older
- Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography.
- Subjects who, in the opinion of the Investigator (based on the current guidelines for clinical practice), have been treated for heart failure for at least 90 days and are currently receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure.
- Subjects who are in New York Heart Association functional Class III and IV at the time of enrollment.
- Subjects who are willing and able to return for all follow-up visits.
Who cannot join
- Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
- Subjects receiving any form of inotropic support within 30 days before enrollment, including subjects on continuous IV inotrope therapy.
- Subjects hospitalized for decompensated heart failure requiring acute treatment with intravenous loop diuretics, IV inotropes or hemofiltration within 30 days before enrollment and baseline testing.
- Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring.
- Subjects having a PR interval greater than 375ms.
- Subjects who are scheduled for a CABG or a PTCA procedure, or who have undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment.
Show all 13Show fewer
- Subjects who have a biventricular pacing system, an accepted indication for such a device, or a QRS width of 130ms or greater.
- Subjects who have had a myocardial infarction within 90 days of enrollment.
- Subjects who have mechanical tricuspid valve.
- Subjects who have a Left Ventricular Assist Device or prior heart transplant.
- Subjects on dialysis.
- Subjects who are participating in another experimental protocol.
- Subjects who are unable to provide informed consent.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Cooper University Hospital
Camden, New Jersey, 08103
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
UT Southwestern Medical Center
Dallas, Texas, 75390
St. Mary Research Institute
Langhorne, Pennsylvania, 19047
Baptist Health Lexington
Lexington, Kentucky, 40503
University of Kentucky
Lexington, Kentucky, 40536
Chan Heart Rhythm Institute
Mesa, Arizona, 85206
Southwest Cardiology Associates
Mesa, Arizona, 85206
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Jefferson Heart Institute
Philadelphia, Pennsylvania, 19047
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Cardiovascular Consultants
Phoenix, Arizona, 85027
Guthrie Medical Group at Robert Packer Hospital
Sayre, Pennsylvania, 18840
Arizona Arrhythmia Consultants
Scottsdale, Arizona, 85251
Pima Heart
Tucson, Arizona, 85745
CHRISTUS Trinity Mother Frances Health System
Tyler, Texas, 75701
About this study
Official title: FIX-HF-5CA: Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%
This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.
Read the detailed description
The Continued Access study is a prospective, non-randomized, multi-center study designed to allow controlled access to the Optimizer Smart System until the PMA order has been issued by the FDA.
- Conditions
- Heart Failure, Congestive Heart Failure, Chronic Heart Disease, CHF
- Being tested
- Optimizer Smart System
- Keywords
- Cardiac Contractility Modulation, CCM, FIX-HF-5CA, Continued Access
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimizer Smart SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Optimizer Smart System | Experimental | All eligible subjects will have the Optimizer Smart System implanted and receive cardiac contractility modulation therapy (CCM). Receives: Device: Optimizer Smart System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Mortality Comparison to the Predicted Probability of Mortality
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.
Measured: 2 years 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start1 Jul 2017
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Why it stopped: The primary objective of the protocol was to allow ongoing access to treatment of patients suffering from moderate to severe heart failure at selected investigational sites until the PMA was approved by the FDA for the OPTIMIZER System.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Continued Access
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Impulse Dynamics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Burkhoff, MD, PhD, Study director, Impulse Dynamics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102437
- Sponsor's protocol ID
- CP OPT2017-004
- Acronym
- FIX-HF-5CA
- Status last verified
- Feb 2021
- First submitted
- 23 Mar 2017
- Last updated
- 23 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIX-HF-5CA: Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%
- ClinicalTrials.gov ID
- NCT03102437
- Acronym / sponsor ID
- FIX-HF-5CA / CP OPT2017-004
- Conditions
- Heart Failure, Congestive Heart Failure, Chronic Heart Disease, CHF
- Keywords
- Cardiac Contractility Modulation, CCM, FIX-HF-5CA, Continued Access
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The primary objective of the protocol was to allow ongoing access to treatment of patients suffering from moderate to severe heart failure at selected investigational sites until the PMA was approved by the FDA for the OPTIMIZER System.
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Impulse DynamicsIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Posted 23 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.
Detailed description
The Continued Access study is a prospective, non-randomized, multi-center study designed to allow controlled access to the Optimizer Smart System until the PMA order has been issued by the FDA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Continued Access
| Arm | Type | Receives |
|---|---|---|
| Optimizer Smart System | Experimental | Device: Optimizer Smart SystemAll eligible subjects will have the Optimizer Smart System implanted and receive cardiac contractility modulation therapy (CCM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who are 18 years of age or older
- Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography.
- Subjects who, in the opinion of the Investigator (based on the current guidelines for clinical practice), have been treated for heart failure for at least 90 days and are currently receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure.
- Subjects who are in New York Heart Association functional Class III and IV at the time of enrollment.
- Subjects who are willing and able to return for all follow-up visits.
Key exclusion criteria (13 listed)
- Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
- Subjects receiving any form of inotropic support within 30 days before enrollment, including subjects on continuous IV inotrope therapy.
- Subjects hospitalized for decompensated heart failure requiring acute treatment with intravenous loop diuretics, IV inotropes or hemofiltration within 30 days before enrollment and baseline testing.
- Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring.
- Subjects having a PR interval greater than 375ms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimizer Smart SystemThe 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. | Device | Optimizer Smart System |
Primary outcome
Observed Mortality Comparison to the Predicted Probability of Mortality
Time frame: 2 years 6 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Burkhoff, MD, PhD study director
Impulse Dynamics
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimizer Smart System in people with Heart Failure and Congestive Heart Failure, run by Impulse Dynamics at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed Mortality Comparison to the Predicted Probability of Mortality (time frame: 2 years 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.