Heart FailureFIX-HF-5C2NCT03339310
Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System
A study testing Optimizer Smart System with 2-leads in people with Heart Failure and Congestive Heart Failure, run by Impulse Dynamics at 10 sites in 2 countries.
Trial summary
This is a multicenter, prospective, single-arm study of the Optimizer Smart System with 2-leads 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 with 2-leads
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 23 Oct 2017to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subject is male or a non-pregnant female
- Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography determined by the echocardiography core laboratory.
- Subjects who have been treated for heart failure for at least 90 days (including treatment with a β-blocker for at least 90 days unless the subject is intolerant) and are in New York Heart Association functional Class III and IV at the time of enrollment.
- Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure according to guideline recommendations. For patients with EF≤35%, this regimen shall consist of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and β-blocker. Angiotensin receptor -neprilysin inhibitor (ARNI) may be substituted for ACE inhibitors or ARBs and Ivabradine may also be considered in subjects with a heart rate >70bpm. Stable is defined as no more than a 100% increase or 50% decrease in dose.
- Subjects who, in the opinion of the Principal Investigator (based on the current guidelines for clinical practice), have a clinical indication for an implanted cardiac defibrillator (ICD, e.g., EF≤35%) and/or pacemaker, must have an existing device unless the patient refuses to undergo the implantation of such device for personal reasons.
- Subjects who are willing and able to return for all follow-up visits.
Who cannot join
- Subjects whose baseline peak VO2 is <9 or >20 ml O2/min/kg. The qualifying CPX test must be deemed adequate.
- Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
- Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days before enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation.
- Subjects hospitalized for heart failure requiring acute treatment with intravenous loop diuretics, IV inotropes or hemofiltration within 30 days before enrollment and baseline testing or subjects receiving any form of positive inotropic support within 30 days before enrollment, including continuous IV inotrope therapy.
- Subjects having a PR interval greater than 375ms.
- Subjects whose exercise tolerance is limited by a condition other than heart failure (e.g., angina, COPD, peripheral vascular disease, orthopedic or rheumatologic conditions) or who are unable to perform baseline stress testing.
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- 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.
- 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 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
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Dallas VA Hospital
Dallas, Texas, 75216
Baptist Health Systems
Lexington, Illinois, 40503
Chan Heart Rhythm Institute
Mesa, Arizona, 85206
Southwest Cardiology Associates
Mesa, Arizona, 85206
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Cardiovascular Consultants
Phoenix, Arizona, 85032
Arizona Arrhythmia Consultants
Scottsdale, Arizona, 85251
Pima Heart Physicians, PC
Tucson, Arizona, 85712
CHRISTUS Trinity Mother Frances
Tyler, Texas, 75701
About this study
Official title: FIX-HF-5C2: Evaluation of the Safety and Efficacy of the 2-lead 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 study of the Optimizer Smart System with 2-leads
Read the detailed description
This is a multicenter, prospective, single-arm treatment only confirmatory study of the 2-lead configuration of the Optimizer Smart System.
- Conditions
- Heart Failure, Congestive Heart Failure, Chronic Heart Disease, CHF
- Being tested
- Optimizer Smart System with 2-leads
- Keywords
- CCM Therapy, 2-Lead, FIX-HF-5C2, Optimizer
- 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 System with 2-leadsDevice
Also called Optimizer Smart System
The Optimizer Smart System with 2-leads delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Implanted subjects receive five non-contiguous one-hour periods of CCM signals per day.
| Study group | Role | What they receive |
|---|---|---|
| Optimizer Smart System with 2-leads | Experimental | All eligible subjects will have the Optimizer Smart System implanted and receive cardiac contractility modulation therapy (CCM). Receives: Device: Optimizer Smart System with 2-leads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise tolerance quantified by peak VO2 measured on cardiopulmonary exercise stress testing (CPX).
Device efficacy will be assessed as change in exercise tolerance quantified by peak VO2 measured on cardiopulmonary exercise stress testing (CPX). Subjects on device under FIX-HF-5C2 protocol will be compared to subjects on control under FIX-HF-5C protocol with respect to peak V02 mean change at 24-weeks from baseline.
Measured: 24 weeks
Optimizer-device and -procedure related complication rate
Subjects experiencing an Optimizer device- or procedure-related complication through the 24-week study period, as determined by an independent events committee.
Measured: 24 weeks
Secondary outcomes (1)
Total CCM delivery comparing 2 and 3-lead device configurations
A comparison will be made between the Optimizer per-protocol groups in the FIX-HF-5C (3-lead) and FIX-HF-5C2 (2-lead) device configurations to show there is no difference between the amount of CCM therapy provided by the two device configurations. Total CCM delivery (effective hours delivered) will be evaluated at the end of 24 weeks following the Optimizer implantation.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start23 Oct 2017
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Optimizer Smart System
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Impulse Dynamics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David D. Gutterman, MD, Study director, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339310
- Sponsor's protocol ID
- CP OPT2017-005
- Other IDs
- FIX-HF-5C2
- Acronym
- FIX-HF-5C2
- Status last verified
- Jan 2020
- First submitted
- 23 Oct 2017
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Wiegn P, Chan R, Jost C, Saville BR, Parise H, Prutchi D, Carson PE, Stagg A, Goldsmith RL, Burkhoff D. Safety, Performance, and Efficacy of Cardiac Contractility Modulation Delivered by the 2-Lead Optimizer Smart System: The FIX-HF-5C2 Study. Circ Heart Fail. 2020 Apr;13(4):e006512. doi: 10.1161/CIRCHEARTFAILURE.119.006512. Epub 2020 Apr 8.
PubMed 32264716
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIX-HF-5C2: Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%
- ClinicalTrials.gov ID
- NCT03339310
- Acronym / sponsor ID
- FIX-HF-5C2 / CP OPT2017-005
- Conditions
- Heart Failure, Congestive Heart Failure, Chronic Heart Disease, CHF
- Keywords
- CCM Therapy, 2-Lead, FIX-HF-5C2, Optimizer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Impulse DynamicsIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
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 study of the Optimizer Smart System with 2-leads
Detailed description
This is a multicenter, prospective, single-arm treatment only confirmatory study of the 2-lead configuration of the Optimizer Smart System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Optimizer Smart System
| Arm | Type | Receives |
|---|---|---|
| Optimizer Smart System with 2-leads | Experimental | Device: Optimizer Smart System with 2-leadsAll 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 (7 listed)
- Subjects who are 18 years of age or older
- Subject is male or a non-pregnant female
- Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography determined by the echocardiography core laboratory.
- Subjects who have been treated for heart failure for at least 90 days (including treatment with a β-blocker for at least 90 days unless the subject is intolerant) and are in New York Heart Association functional Class III and IV at the time of enrollment.
- Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure according to guideline recommendations. For patients with EF≤35%, this regimen shall consist of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and β-blocker. Angiotensin receptor -neprilysin inhibitor (ARNI) may be substituted for ACE inhibitors or ARBs and Ivabradine may also be considered in subjects with a heart rate >70bpm. Stable is defined as no more than a 100% increase or 50% decrease in dose.
Key exclusion criteria (14 listed)
- Subjects whose baseline peak VO2 is <9 or >20 ml O2/min/kg. The qualifying CPX test must be deemed adequate.
- Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
- Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days before enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation.
- Subjects hospitalized for heart failure requiring acute treatment with intravenous loop diuretics, IV inotropes or hemofiltration within 30 days before enrollment and baseline testing or subjects receiving any form of positive inotropic support within 30 days before enrollment, including continuous IV inotrope therapy.
- 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 System with 2-leadsAlso: Optimizer Smart SystemThe Optimizer Smart System with 2-leads delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Implanted subjects receive five non-contiguous one-hour periods of CCM signals per day. | Device | Optimizer Smart System with 2-leads |
Primary outcome
Change in exercise tolerance quantified by peak VO2 measured on cardiopulmonary exercise stress testing (CPX).
Time frame: 24 weeks
Device efficacy will be assessed as change in exercise tolerance quantified by peak VO2 measured on cardiopulmonary exercise stress testing (CPX). Subjects on device under FIX-HF-5C2 protocol will be compared to subjects on control under FIX-HF-5C protocol with respect to peak V02 mean change at 24-weeks from baseline.
Optimizer-device and -procedure related complication rate
Time frame: 24 weeks
Subjects experiencing an Optimizer device- or procedure-related complication through the 24-week study period, as determined by an independent events committee.
1 secondary outcome
Total CCM delivery comparing 2 and 3-lead device configurations
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Derived from this study: PubMed 32264716Wiegn P, Chan R, Jost C, Saville BR, Parise H, Prutchi D, Carson PE, Stagg A, Goldsmith RL, Burkhoff D. Safety, Performance, and Efficacy of Cardiac Contractility Modulation Delivered by the 2-Lead Optimizer Smart System: The FIX-HF-5C2 Study. Circ Heart Fail. 2020 Apr;13(4):e006512. doi: 10.1161/CIRCHEARTFAILURE.119.006512. Epub 2020 Apr 8.
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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.
David D. Gutterman, MD study director
Medical College of Wisconsin
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimizer Smart System with 2-leads in people with Heart Failure and Congestive Heart Failure, run by Impulse Dynamics at 10 sites in 2 countries.
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 7 inclusion and 14 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: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in exercise tolerance quantified by peak VO2 measured on cardiopulmonary exercise stress testing (CPX). (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03339310, which also lists 1 linked publication.
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 14 Jan 2020.