Heart FailureHFpEFNCT01045291
Pacing for Heart Failure With Preserved Ejection Fraction
A study testing Cardiac Resynchronization Therapy-Defibrillator (CRT-D) in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in 2 countries.
Trial summary
The purpose of this research study is to evaluate the safety of a new pacing method (Fusion Pacing) for heart failure patients with an ejection fraction (EF) greater than 50% over a period of 4 months, and determine the effects on different measures of 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?
- Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2010to Jan 2013
- 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 with quantitative ejection fraction (EF) of greater than 50 percent
- Patients with active heart failure (symptomatic American Heart Association/American College of Cardiology stage C) despite optimal medications
- Patients greater than 18 years of age
- Patients willing and able to give informed consent
- Patients available for appropriate follow-up times for the length of study
- Patients able to complete cardiopulmonary exercise (CPX) testing
- Patients expected lifespan is greater than 12 months beyond study enrollment
- Patients with a regional mechanical delay (RMD) (septal-lateral) greater than 65 milliseconds
Who cannot join
- Patients who have undergone cardiac surgery 60 days prior to enrollment
- Patients who have had a myocardial infarction 90 days prior to enrollment
- Patients with hemodynamically significant uncorrected cardiac valvular disease
- Patients with active myocarditis and amyloidosis (if documented)
- Patients with a permanent pacemaker
- Patients with creatinine greater than 2 milligrams per milliliter or estimated glomerular filtration rate (eGFR) less than 30 to 50 milliliters per hour
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- Patients with permanent or chronic sustained atrial fibrillation (fibrillation lasting 7 days or more at a time)
- Patients with a PR interval greater than 250 milliseconds
- Patients with severe chronic obstructive pulmonary disease
- Patients with high risk coronary artery disease
- Patients who are or expect to become pregnant during this study
- Patients enrolled in concurrent studies which could confound the results of this study
- Patients with hypertrophic cardiomyopathy (obstructive or non-obstructive)
- Patients with infiltrative disease or restrictive cardiomyopathy
- Patients with indication for percutaneous coronary intervention (PCI) at enrollment
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The purpose of this research study is to evaluate the safety of a new pacing method (Fusion Pacing) for heart failure patients with an ejection fraction (EF) greater than 50% over a period of 4 months, and determine the effects on different measures of heart failure. This new pacing method may allow the heart to pump more efficiently. Participation in this study will last approximately 8 months.
Read the detailed description
Patients with an EF greater than 50% and a regional mechanical delay of >= 65ms (an indication of mechanical dyssynchrony) will receive an implantable cardioverter defibrillator (ICD) with a special pacing feature. When the feature is active, the device wil pace the left ventricle to target improved pump efficiency. Patients will have the feature active for 4 months and inactive for 4 months. The order will be randomized and the patient will not know whether the pacing is active or not. Echocardiography, biomarkers, exercise testing, quality of life (QOL) testing and device information will be used to compare the patient's status while the feature is active vs. inactive.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization Therapy-Defibrillator (CRT-D)Device
Also called Fusion Pacing Investigational Software, Fusion Pacing is an algorithm that is downloaded for use in InSync Sentry™ or InSync Maximo™ devices.
Market approved InSync Sentry™ model 7298, dual chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT) including sequential biventricular pacing and OptiVol® fluid monitoring or market approved InSync Maximo™ model 7304 dual chamber ICD with CRT including sequential biventricular pacing.
| Study group | Role | What they receive |
|---|---|---|
| Fusion Pacing OFF | Active comparator | Subjects initially randomized to the Fusion Pacing OFF Arm will receive the Fusion Pacing software download at the implant visit, but the Fusion Pacing software will be programmed OFF. At 4 months subjects in this arm will crossover to the Fusion Pacing ON Arm. Receives: Device: Cardiac Resynchronization Therapy-Defibrillator (CRT-D) |
| Fusion Pacing ON | Experimental | Subjects initially randomized to the Fusion Pacing ON Arm will receive the Fusion Pacing software download at the implant visit, and the Fusion Pacing software will be programmed ON. At 4 months subjects in this arm will crossover to the Fusion Pacing OFF Arm. Receives: Device: Cardiac Resynchronization Therapy-Defibrillator (CRT-D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events while the Fusion Pacing download is active vs. inactive.
Measured: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Percentage of time the Fusion Pacing is active throughout a four-month follow-up period.
Measured: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Secondary outcomes (4)
Change in Minnesota Living with Heart Failure Questionnaire score.
Measured: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Change in peak VO2 during Cardio-pulmonary Exercise Testing (CPX).
Measured: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Change in echocardiography measures: E/E', Ejection Fraction, LV EDV.
Measured: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Change in NT-proBNP.
Measured: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2013
- Study completionJan 2013
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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- HFpEF Trial Leader, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045291
- Sponsor's protocol ID
- MDT0095101
- Acronym
- HFpEF
- Status last verified
- May 2013
- First submitted
- 8 Jan 2010
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacing for Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT01045291
- Acronym / sponsor ID
- HFpEF / MDT0095101
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Jan 2010 (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 research study is to evaluate the safety of a new pacing method (Fusion Pacing) for heart failure patients with an ejection fraction (EF) greater than 50% over a period of 4 months, and determine the effects on different measures of heart failure. This new pacing method may allow the heart to pump more efficiently. Participation in this study will last approximately 8 months.
Detailed description
Patients with an EF greater than 50% and a regional mechanical delay of >= 65ms (an indication of mechanical dyssynchrony) will receive an implantable cardioverter defibrillator (ICD) with a special pacing feature. When the feature is active, the device wil pace the left ventricle to target improved pump efficiency. Patients will have the feature active for 4 months and inactive for 4 months. The order will be randomized and the patient will not know whether the pacing is active or not. Echocardiography, biomarkers, exercise testing, quality of life (QOL) testing and device information will be used to compare the patient's status while the feature is active vs. inactive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fusion Pacing OFF | Active comparator | Device: Cardiac Resynchronization Therapy-Defibrillator (CRT-D)Subjects initially randomized to the Fusion Pacing OFF Arm will receive the Fusion Pacing software download at the implant visit, but the Fusion Pacing software will be programmed OFF. At 4 months subjects in this arm will crossover to the Fusion Pacing ON Arm. |
| Fusion Pacing ON | Experimental | Device: Cardiac Resynchronization Therapy-Defibrillator (CRT-D)Subjects initially randomized to the Fusion Pacing ON Arm will receive the Fusion Pacing software download at the implant visit, and the Fusion Pacing software will be programmed ON. At 4 months subjects in this arm will crossover to the Fusion Pacing OFF Arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with quantitative ejection fraction (EF) of greater than 50 percent
- Patients with active heart failure (symptomatic American Heart Association/American College of Cardiology stage C) despite optimal medications
- Patients greater than 18 years of age
- Patients willing and able to give informed consent
- Patients available for appropriate follow-up times for the length of study
Key exclusion criteria (15 listed)
- Patients who have undergone cardiac surgery 60 days prior to enrollment
- Patients who have had a myocardial infarction 90 days prior to enrollment
- Patients with hemodynamically significant uncorrected cardiac valvular disease
- Patients with active myocarditis and amyloidosis (if documented)
- Patients with a permanent pacemaker
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 |
|---|---|---|
| Cardiac Resynchronization Therapy-Defibrillator (CRT-D)Also: Fusion Pacing Investigational Software, Fusion Pacing is an algorithm that is downloaded for use in InSync Sentry™ or InSync Maximo™ devices.Market approved InSync Sentry™ model 7298, dual chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT) including sequential biventricular pacing and OptiVol® fluid monitoring or market approved InSync Maximo™ model 7304 dual chamber ICD with CRT including sequential biventricular pacing. | Device | Fusion Pacing OFF, Fusion Pacing ON |
Primary outcome
Number of adverse events while the Fusion Pacing download is active vs. inactive.
Time frame: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Percentage of time the Fusion Pacing is active throughout a four-month follow-up period.
Time frame: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
4 secondary outcomes
Change in Minnesota Living with Heart Failure Questionnaire score.
Time frame: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Change in peak VO2 during Cardio-pulmonary Exercise Testing (CPX).
Time frame: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Change in echocardiography measures: E/E', Ejection Fraction, LV EDV.
Time frame: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
Change in NT-proBNP.
Time frame: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
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 30 May 2013.
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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.
HFpEF Trial Leader study chair
Medtronic
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Resynchronization Therapy-Defibrillator (CRT-D) in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 2 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 8 inclusion and 15 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 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Taiwan. 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?
Number of adverse events while the Fusion Pacing download is active vs. inactive. (time frame: From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit). 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?
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 30 May 2013.