Heart FailurePhase 2DEFEAT-HFNCT01112579
Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure
A Phase 2 study testing Medtronic PrimeADVANCED Neurostimulator in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 19 sites in 8 countries.
Trial summary
The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Medtronic PrimeADVANCED Neurostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 19 sitesin 8 countries
- Study dates
- Apr 2010to Apr 2015
- Phase
- Phase 2
- 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
- Left Ventricular Ejection Fraction (LVEF) of 35 percent or less
- New York Heart Association (NYHA) functional Class III at time of screening
- QRS duration less than 120 milliseconds (ms)
- Left Ventricular End Diastolic Diameter (LVEDD) of 55 millimeters (mm) to 80 mm as determined by echocardiography within the past 6 months
- Receiving stable optimal medical therapy for heart failure prior to enrollment
- Serum creatinine less than or equal to 3.0 milligrams per deciliter (mg/dL)
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- 18 years of age or older
- Willing and able to comply with study procedures
- Expected lifespan greater than 12 months beyond study enrollment as assessed by physician
Who cannot join
- Interruption of thromboprophylaxis (e.g., heparin, LMWH, warfarin, aspirin, dabigatran, clopidogrel) would pose an unacceptable health risk (e.g., patient with an abnormal bleeding time), as determined by physician
- Polyneuropathy
- Requires diathermy including shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy
- Unable to perform an exercise capacity test
- Pregnant or planning to become pregnant during this study
- Currently enrolled or plans to enroll in another investigational device or drug study that may confound the results of this study
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- Had Coronary Artery Bypass Graft/Percutaneous Coronary Intervention/Bare Metal Stent (CABG/PCI/BMS) procedures within the past 90 days
- Had a heart transplant
- Has complete heart block
- Had Acute Coronary Syndrome within the past 90 days
- Has congenital heart disease with significant hemodynamic shunting
- Has chemotherapy-induced heart failure
- Has reversible cardiomyopathy
- Has severe mitral regurgitation (greater than 60 percent regurgitant fraction or greater than 0.3 centimeters squared (cm2) regurgitant orifice area)
- Has diagnosed unstable angina pectoris
- Has unstable coronary artery disease
- Has a Cardiac Resynchronization Therapy (CRT) device implanted and is receiving CRT therapy
- Has a non-Medtronic Implantable Cardioverter Defibrillator (ICD), pacemaker, or any non-transvenous defibrillation lead
- Has a Medtronic ICD whose sensing threshold cannot be programmed to 0.3mV or greater
- Has an existing neurostimulator
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
United States6 sites
Study site
Allentown, Pennsylvania
Study site
Burlington, Vermont
Study site
Indianapolis, Indiana
Study site
Miami, Florida
Study site
Philadelphia, Pennsylvania
Study site
Spokane, Washington
Netherlands3 sites
Study site
Groningen
Study site
Maastricht
Study site
Zwolle
Canada2 sites
Study site
Vancouver, British Columbia
Study site
Victoria, British Columbia
About this study
The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.
- Conditions
- Heart Failure
- Being tested
- Medtronic PrimeADVANCED Neurostimulator
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic PrimeADVANCED NeurostimulatorDevice
Heart failure therapy
Medtronic PrimeADVANCED NeurostimulatorDevice
Also called Medical management
Medical management
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Medtronic PrimeADVANCED Neurostimulator |
| Control | Other | Not described Receives: Device: Medtronic PrimeADVANCED Neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm.
Measured: Baseline and 6 months
Secondary outcomes (2)
Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months
Measured: Baseline and 6 Months
Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months
Measured: Baseline and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2014
- Study completionApr 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas P Zipes, M.D., Principal investigator, Krannert Institute of CardiologyHeinz Theres, M.D., Principal investigator, Charite Universitatsmedizin Berlin - Campus Charite Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112579
- Sponsor's protocol ID
- DEFEAT-HF
- Acronym
- DEFEAT-HF
- Status last verified
- Oct 2015
- First submitted
- 16 Apr 2010
- Last updated
- 29 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zipes DP, Neuzil P, Theres H, Caraway D, Mann DL, Mannheimer C, Van Buren P, Linde C, Linderoth B, Kueffer F, Sarazin SA, DeJongste MJL; DEFEAT-HF Trial Investigators. Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Systolic Heart Failure: The DEFEAT-HF Study. JACC Heart Fail. 2016 Feb;4(2):129-136. doi: 10.1016/j.jchf.2015.10.006. Epub 2015 Dec 9.
PubMed 26682789
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01112579
- Acronym / sponsor ID
- DEFEAT-HF / DEFEAT-HF
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Posted 29 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Medtronic PrimeADVANCED Neurostimulator |
| Control | Other | Device: Medtronic PrimeADVANCED Neurostimulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Left Ventricular Ejection Fraction (LVEF) of 35 percent or less
- New York Heart Association (NYHA) functional Class III at time of screening
- QRS duration less than 120 milliseconds (ms)
- Left Ventricular End Diastolic Diameter (LVEDD) of 55 millimeters (mm) to 80 mm as determined by echocardiography within the past 6 months
- Receiving stable optimal medical therapy for heart failure prior to enrollment
Key exclusion criteria (20 listed)
- Interruption of thromboprophylaxis (e.g., heparin, LMWH, warfarin, aspirin, dabigatran, clopidogrel) would pose an unacceptable health risk (e.g., patient with an abnormal bleeding time), as determined by physician
- Polyneuropathy
- Requires diathermy including shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy
- Unable to perform an exercise capacity test
- Pregnant or planning to become pregnant during this study
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 |
|---|---|---|
| Medtronic PrimeADVANCED NeurostimulatorHeart failure therapy | Device | Treatment |
| Medtronic PrimeADVANCED NeurostimulatorAlso: Medical managementMedical management | Device | Control |
Primary outcome
Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm.
Time frame: Baseline and 6 months
2 secondary outcomes
Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months
Time frame: Baseline and 6 Months
Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months
Time frame: Baseline and 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26682789Zipes DP, Neuzil P, Theres H, Caraway D, Mann DL, Mannheimer C, Van Buren P, Linde C, Linderoth B, Kueffer F, Sarazin SA, DeJongste MJL; DEFEAT-HF Trial Investigators. Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Systolic Heart Failure: The DEFEAT-HF Study. JACC Heart Fail. 2016 Feb;4(2):129-136. doi: 10.1016/j.jchf.2015.10.006. Epub 2015 Dec 9.
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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.
Douglas P Zipes, M.D. principal investigator
Krannert Institute of Cardiology
Heinz Theres, M.D. principal investigator
Charite Universitatsmedizin Berlin - Campus Charite Mitte
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medtronic PrimeADVANCED Neurostimulator in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 19 sites in 8 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 9 inclusion and 20 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 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Netherlands, Canada, Germany, South Africa and 3 more countries. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2015). 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?
Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm. (time frame: Baseline and 6 months). 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 NCT01112579, 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 29 Oct 2015.