Heart FailureTAME-HFNCT01820130
Trial of Autonomic neuroModulation for trEatment of Chronic Heart Failure
A study testing St Jude Medical EON mini rechargeable system in people with Heart Failure, run by Abbott Medical Devices at 1 site in France.
Trial summary
The purpose of this clinical investigation is to evaluate the safety and efficacy of Spinal Cord Stimulation (SCS) in advanced heart failure (HF) patients with Implantable Cardioverter Defibrillator (ICD) but not indicated for Cardiac Resynchronization Therapy (CRT). 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?
- St Jude Medical EON mini rechargeable system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Sep 2016
- 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
- Patients has a Left Ventricular Ejection Fraction (LVEF) less than or equal to 35%
- Patient is in New York Heart Association (NYHA) Class III
- Patient has a QRS duration <120 ms (non-paced QRS, at the time of device Implant or protocol inclusion)
- Patient has had an ICD implanted for >90 days
- Patient is receiving stable and optimal medical therapy for HF (>90 days) as describe by "European Society of Cardiology 2012 recommendation for diagnosis and treatment of acute and chronic Heart Failure", except in case of contraindication or allergy
- Patient is able to provide written Informed Consent prior to any investigational related procedure
Who cannot join
- Patient currently has an implanted spinal cord stimulator or previously had an implanted spinal cord stimulator which is now explanted or has had previous spinal surgery that would interfere with implant of percutaneous SCS leads in the upper thoracic region
- Patient has polyneuropathy
- Patient requires short-wave diathermy, microwave diathermy or therapeutic ultrasound diathermy
- Patient is in NYHA class IV
- Patient has received a tissue / organ transplant or is expected to have a tissue / organ transplant within the next 180 days
- Patient has a cardiac resynchronization therapy (CRT) device, or LV Assist device or is expected to receive CRT, or left ventricular assist device (LVAD) within the next 180 days
Show all 26Show fewer
- Patient has critical valvular heart disease that requires valve repair or replacement
- Patient has had a myocardial infarction (MI) or cardiac revascularization procedure (percutaneous coronary intervention or coronary artery bypass graft) within 90 days of enrollment
- Patient is on IV inotropic therapy
- Patient has active myocarditis or early postpartum cardiomyopathy
- Patient has taken any of the following drugs within 30 days of enrollment: systemic corticosteroids, cytostatic and immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), DNA depleting or cytotoxic drugs
- Patient is pregnant, or of childbearing potential and is not using adequate contraceptive methods, or nursing
- Patient with a bleeding tendency (INR >1.2 and platelet count <100 x109 per liter)
- Patient has a local infection at the ICD implant location or systemic infection
- Patient has renal insufficiency (creatinine >3.0 mg/dl)
- Patient with risk of allergy to SCS device component materials
- Patient having one of the following condition must be considered as non relevant for SCS implantation:
- / Patient with active stent
- / Patient having bare metal stent for less than 6 months
- / Patient presented with an acute coronary syndrome within the last 6 months
- / Patient with stent on the common
- / Patient with a history of stent thrombosis
- / Coronary Patient receiving double antiplatelet medication
- Patient is participating in another clinical study with an active treatment arm
- Patient is less than 18 years old
- Patient's life's expectancy is less than 1 year as assessed by investigators
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical investigation is to evaluate the safety and efficacy of Spinal Cord Stimulation (SCS) in advanced heart failure (HF) patients with Implantable Cardioverter Defibrillator (ICD) but not indicated for Cardiac Resynchronization Therapy (CRT).
- Conditions
- Heart Failure
- Being tested
- St Jude Medical EON mini rechargeable system
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
St Jude Medical EON mini rechargeable systemDevice
Also called Eon Mini Neurostimulation System (IPG Model 3788)
implantation of Eon Mini Neurostimulation System (IPG Model 3788)
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation system therapy | Experimental | St Jude Medical EON mini rechargeable system Receives: Device: St Jude Medical EON mini rechargeable system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Marker of Cardiac remodeling via Left Ventricular End Diastolic Volume (LVEDV) of Patient with advanced HF
Evaluation of left ventricular end diastolic volume (LVEDV) as measured by cardiac echo between baseline and after 6 months of SCS therapy.
Measured: baseline and 6 Months
Efficacy Marker of patient symptom via NYHA class for patient with advanced HF
Evaluation of NYHA class as marker of patient symptom between baseline and after 6 months of SCS therapy.
Measured: Baseline and 6 months
Efficacy Marker of patient symptom via 6 Minutes Hall Walk distance for patient with advanced HF
Evaluation of 6 Minutes Hall walk (6MHW) as marker of patient symptom between baseline and after 6 months of SCS therapy.
Measured: baseline to 6 months
Secondary outcomes (4)
Safety composite marker of SCS therapy for patient with HF and ICD device
Report of cardiovascular event, arrythmias, devices interaction, procedural and post-procedural events analyzed in a global composite way.
Measured: baseline and 6 months
Additional efficacy markers of SCS therapy on patient symptom via Quality Of Life questionnaire
Endpoint measurements of patient-reported quality of life after 6 months of therapy.
Measured: baseline to 6 months
Additional efficacy markers of SCS therapy on patient symptom via Maximal exercise test tolerance
Additional endpoint measurements include exercise tolerance between baseline and 6 months via cardiopulmonary test, including maximum level of exercise and heart rhythm.
Measured: baseline and 6 months
Additional efficacy markers of SCS therapy on cardiac function via echocardiography
Additional endpoint measurements include standard echocardiography markers of LV structure and function including systolic and diastolic performance and cardiac dimensions as a marker of structural reverse remodeling
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 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Why it stopped: end of inclusion period without patient enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Bordachar, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820130
- Sponsor's protocol ID
- CR-12-047-FR-SC
- Acronym
- TAME-HF
- Status last verified
- Feb 2019
- First submitted
- 22 Feb 2013
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Autonomic neuroModulation for trEatment of Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01820130
- Acronym / sponsor ID
- TAME-HF / CR-12-047-FR-SC
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: end of inclusion period without patient enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 28 Mar 2013 (estimated)
- 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.
The purpose of this clinical investigation is to evaluate the safety and efficacy of Spinal Cord Stimulation (SCS) in advanced heart failure (HF) patients with Implantable Cardioverter Defibrillator (ICD) but not indicated for Cardiac Resynchronization Therapy (CRT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation system therapy | Experimental | Device: St Jude Medical EON mini rechargeable systemSt Jude Medical EON mini rechargeable system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients has a Left Ventricular Ejection Fraction (LVEF) less than or equal to 35%
- Patient is in New York Heart Association (NYHA) Class III
- Patient has a QRS duration <120 ms (non-paced QRS, at the time of device Implant or protocol inclusion)
- Patient has had an ICD implanted for >90 days
- Patient is receiving stable and optimal medical therapy for HF (>90 days) as describe by "European Society of Cardiology 2012 recommendation for diagnosis and treatment of acute and chronic Heart Failure", except in case of contraindication or allergy
Key exclusion criteria (26 listed)
- Patient currently has an implanted spinal cord stimulator or previously had an implanted spinal cord stimulator which is now explanted or has had previous spinal surgery that would interfere with implant of percutaneous SCS leads in the upper thoracic region
- Patient has polyneuropathy
- Patient requires short-wave diathermy, microwave diathermy or therapeutic ultrasound diathermy
- Patient is in NYHA class IV
- Patient has received a tissue / organ transplant or is expected to have a tissue / organ transplant within the next 180 days
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 |
|---|---|---|
| St Jude Medical EON mini rechargeable systemAlso: Eon Mini Neurostimulation System (IPG Model 3788)implantation of Eon Mini Neurostimulation System (IPG Model 3788) | Device | Spinal Cord Stimulation system therapy |
Primary outcome
Efficacy Marker of Cardiac remodeling via Left Ventricular End Diastolic Volume (LVEDV) of Patient with advanced HF
Time frame: baseline and 6 Months
Evaluation of left ventricular end diastolic volume (LVEDV) as measured by cardiac echo between baseline and after 6 months of SCS therapy.
Efficacy Marker of patient symptom via NYHA class for patient with advanced HF
Time frame: Baseline and 6 months
Evaluation of NYHA class as marker of patient symptom between baseline and after 6 months of SCS therapy.
Efficacy Marker of patient symptom via 6 Minutes Hall Walk distance for patient with advanced HF
Time frame: baseline to 6 months
Evaluation of 6 Minutes Hall walk (6MHW) as marker of patient symptom between baseline and after 6 months of SCS therapy.
4 secondary outcomes
Safety composite marker of SCS therapy for patient with HF and ICD device
Time frame: baseline and 6 months
Additional efficacy markers of SCS therapy on patient symptom via Quality Of Life questionnaire
Time frame: baseline to 6 months
Additional efficacy markers of SCS therapy on patient symptom via Maximal exercise test tolerance
Time frame: baseline and 6 months
Additional efficacy markers of SCS therapy on cardiac function via echocardiography
Time frame: baseline and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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.
Pierre Bordachar, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing St Jude Medical EON mini rechargeable system in people with Heart Failure, run by Abbott Medical Devices at 1 site in France.
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 6 inclusion and 26 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: withdrawn, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 was withdrawn before enrolling participants, so there are no results.
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?
Efficacy Marker of Cardiac remodeling via Left Ventricular End Diastolic Volume (LVEDV) of Patient with advanced HF (time frame: baseline and 6 Months). The study lists 3 primary outcomes in all. 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 4 Feb 2019.