Heart Failure, SystolicNCT03305692
ECG Belt vs. Echocardiographic Optimization of CRT
A study testing Optimization of CRT Device in people with Heart Failure, Systolic, run by Alan J. Bank, MD at 1 site in United States.
Trial summary
Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with systolic heart failure for over 15 years. Despite years of research, there is a still a 25-40% non-responder rate depending on the outcomes measured. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- Optimization of CRT Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2017to 17 Aug 2021
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent for participation in the study
- Age ≥18 years
- Received a first-time CRT device for standard clinical indication (can be upgraded from non-CRT pacemaker or defibrillator if ventricular pacing < 10%)
- Adequate echocardiographic images for EF \& LVESV determination
Who cannot join
- Unhealed open wounds on the torso and/or a history of documented severe allergic reactions from ECG electrode gel
- Enrollment in a concurrent study that could confound the results of this study
- Pregnant or could become pregnant within the 6 month follow-up period
- Non-ischemic cardiomyopathy, LBBB morphology, and QRSd > 150 ms
- Dysrhythmia (AF or PVCs) that will likely result in aggregate ventricular pacing < 90% over the 6 month follow-up period
Trial locations and contacts
1 site in 1 country.
United States1 site
United Heart & Vascular Clinic
Saint Paul, Minnesota, 55102
About this study
Official title: Optimization of New CRT Recipients: Subjects Randomized to ECG Belt or Echocardiographic Optimization
Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with systolic heart failure for over 15 years. Despite years of research, there is a still a 25-40% non-responder rate depending on the outcomes measured. CRT optimization is a term used to describe the act of individualizing the therapy (CRT programming) for an individual patient. This is not often performed, but when it is, echocardiography is utilized. Recent work of body surface mapping using a novel system called the ECG Belt has shown a relationship between measures of electrical dyssynchrony and acute and chronic heart pumping function. This study will compare outcomes of patients randomized to either echocardiographic or ECG Belt optimization of CRT devices.
Read the detailed description
This is a prospective randomized study designed to determine whether cardiac resynchronization therapy (CRT) device programming guided by the ECG Belt (Medtronic, PLC) improves echocardiographic and functional outcomes in heart failure (HF) patients. The population will include patients treated with CRT for standard indications (not implanted for the sole purposes of this study). The study will focus enrollment on patients who do not have baseline characteristics predicting the best CRT response. Therefore the study will not enroll patients having non-ischemic HF etiology, left bundle branch (LBBB) morphology, and QRSd > 150 ms or those previously RV paced.
- Conditions
- Heart Failure, Systolic
- Being tested
- Optimization of CRT Device
- Keywords
- cardiac resynchronization therapy, pacing, echocardiography, optimization, heart failure
- Medical subject headings
- Heart Failure, Systolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimization of CRT DeviceDiagnostic test
Use a body surface mapping system to quantify electrical dyssynchrony or echocardiography to quantify diastolic blood flow characteristics. Program the pacemaker to maximize the benefit of the modality the subject is randomized to.
| Study group | Role | What they receive |
|---|---|---|
| ECG Belt | Experimental | Use ECG Belt body surface mapping system to optimize CRT programming. Receives: Diagnostic Test: Optimization of CRT Device |
| Echocardiography | Experimental | Use mitral inflow echocardiography to optimize CRT programming. Receives: Diagnostic Test: Optimization of CRT Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic assessment of LV function
Change in ejection fraction
Measured: 6 months post optimization
Echocardiographic assessment of LV size
Change in left ventricular end-systolic volume
Measured: 6 months post optimization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start31 Oct 2017
- Primary completion17 Aug 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies 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
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alan J. Bank, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Alan J. Bank, MD, Allina Health System
- Investigators
- Alan Bank, MD, Principal investigator, United Heart & Vascular Clinic - Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305692
- Sponsor's protocol ID
- ERP 3890
- Status last verified
- Sep 2021
- First submitted
- 26 Sep 2017
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not plan to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of New CRT Recipients: Subjects Randomized to ECG Belt or Echocardiographic Optimization
- ClinicalTrials.gov ID
- NCT03305692
- Acronym / sponsor ID
- ERP 3890
- Conditions
- Heart Failure, Systolic
- Keywords
- cardiac resynchronization therapy, pacing, echocardiography, optimization, heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Alan J. Bank, MDUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 10 Oct 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.
Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with systolic heart failure for over 15 years. Despite years of research, there is a still a 25-40% non-responder rate depending on the outcomes measured. CRT optimization is a term used to describe the act of individualizing the therapy (CRT programming) for an individual patient. This is not often performed, but when it is, echocardiography is utilized. Recent work of body surface mapping using a novel system called the ECG Belt has shown a relationship between measures of electrical dyssynchrony and acute and chronic heart pumping function. This study will compare outcomes of patients randomized to either echocardiographic or ECG Belt optimization of CRT devices.
Detailed description
This is a prospective randomized study designed to determine whether cardiac resynchronization therapy (CRT) device programming guided by the ECG Belt (Medtronic, PLC) improves echocardiographic and functional outcomes in heart failure (HF) patients. The population will include patients treated with CRT for standard indications (not implanted for the sole purposes of this study). The study will focus enrollment on patients who do not have baseline characteristics predicting the best CRT response. Therefore the study will not enroll patients having non-ischemic HF etiology, left bundle branch (LBBB) morphology, and QRSd > 150 ms or those previously RV paced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| ECG Belt | Experimental | Diagnostic Test: Optimization of CRT DeviceUse ECG Belt body surface mapping system to optimize CRT programming. |
| Echocardiography | Experimental | Diagnostic Test: Optimization of CRT DeviceUse mitral inflow echocardiography to optimize CRT programming. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing and able to provide informed consent for participation in the study
- Age ≥18 years
- Received a first-time CRT device for standard clinical indication (can be upgraded from non-CRT pacemaker or defibrillator if ventricular pacing < 10%)
- Adequate echocardiographic images for EF \& LVESV determination
Key exclusion criteria (5 listed)
- Unhealed open wounds on the torso and/or a history of documented severe allergic reactions from ECG electrode gel
- Enrollment in a concurrent study that could confound the results of this study
- Pregnant or could become pregnant within the 6 month follow-up period
- Non-ischemic cardiomyopathy, LBBB morphology, and QRSd > 150 ms
- Dysrhythmia (AF or PVCs) that will likely result in aggregate ventricular pacing < 90% over the 6 month follow-up period
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 |
|---|---|---|
| Optimization of CRT DeviceUse a body surface mapping system to quantify electrical dyssynchrony or echocardiography to quantify diastolic blood flow characteristics. Program the pacemaker to maximize the benefit of the modality the subject is randomized to. | Diagnostic test | ECG Belt, Echocardiography |
Primary outcome
Echocardiographic assessment of LV function
Time frame: 6 months post optimization
Change in ejection fraction
Echocardiographic assessment of LV size
Time frame: 6 months post optimization
Change in left ventricular end-systolic volume
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 27 Sep 2021.
- Individual participant dataSharing planned: No. We do not plan to share IPD with other researchers.
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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.
Alan Bank, MD principal investigator
United Heart & Vascular Clinic - Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimization of CRT Device in people with Heart Failure, Systolic, run by Alan J. Bank, MD at 1 site 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 4 inclusion and 5 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 27 Sep 2021. 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 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?
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?
Echocardiographic assessment of LV function (time frame: 6 months post optimization). 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 27 Sep 2021.