Heart FailureNCT03504020
ECG Belt for CRT Response
A study testing ECG Belt Research System in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 43 sites in 7 countries.
Trial summary
The purpose of this clinical study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling. 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?
- ECG Belt Research System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 43 sitesin 7 countries
- Study dates
- 13 Jul 2018to 20 Apr 2022
- Phase
- Interventional
- 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
- Indicated for CRT, with QRS duration ≥130 ms, and planned to be implanted with a market-released Medtronic CRT device with AdaptivCRT and a Medtronic quadripolar LV lead.
- Meets at least one of the following criteria: QRS duration < 150 ms, Prior documented Myocardial Infarction, Non-LBBB
- LVEDD ≥ 55 mm, as determined by site
Who cannot join
- Permanent/persistent AF or presenting with AF
- Pre-existing or previous LV lead or other confounding devices e.g. Left Ventricular Assist Device, Vagal Nerve Stimulator
- Currently implanted with IPG or ICD with > 10% RV pacing
- Permanent complete AV block
- Enrolled in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study.
- Less than 1 year life expectancy
- Vulnerable adults
- Younger than 18 years of age
Trial locations and contacts
43 sites in 7 countries.
43 sites in 7 countries
United States34 sites
Lehigh Valley Hospital- Cedar Crest
Allentown, Pennsylvania, 18103
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
The University of Vermont Medical Center
Burlington, Vermont, 05401-1473
Medical University of South Carolina
Charleston, South Carolina, 29425-0001
Atrium Health's Carolina Medical Center
Charlotte, North Carolina, 28203-5867
Cleveland Clinic
Cleveland, Ohio, 44195
Mount Carmel East
Columbus, Ohio, 43213
OhioHealth Research and Innovation Institute (OHRI)
Columbus, Ohio, 43214
Duke University Medical Center
Durham, North Carolina, 27710
NorthShore University Health System
Evanston, Illinois, 60201-1718
Texas Health Research & Education Institute
Fort Worth, Texas, 76104
University of Florida Health Shands Hospital
Gainesville, Florida, 32608
Hartford Hospital
Hartford, Connecticut, 06102
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Saint Lukes Hospital of Kansas City
Kansas City, Missouri, 64111
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660-7332
Bryan Heart
Lincoln, Nebraska, 68506
Aurora St. Lukes
Milwaukee, Wisconsin, 53215
Morristown Memorial Hospital
Morristown, New Jersey, 07960-6136
Vanderbilt University medical Center
Nashville, Tennessee, 37232-8802
Yale School of Medicine
New Haven, Connecticut, 06510
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Florida Hospital Cardiovascular Research Institute
Orlando, Florida, 32803-1248
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213-2536
North Carolina Heart and Vascular
Raleigh, North Carolina, 27607-7521
Mayo Clinic
Rochester, Minnesota, 55905
Advanced Cardiovascular Specialists
Shreveport, Louisiana, 71105
Washington University School of Medicine
St Louis, Missouri, 63110
BayCare Health System
Tampa, Florida, 33614-7101
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Iowa Heart Center
West Des Moines, Iowa, 50266
Heartland Cardiology
Wichita, Kansas, 67205-1138
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
Belgium2 sites
Onze-Lieve-Vrouwziekenhuis-campus aalst
Aalst, 9300
Cliniques Universitaires Saint-Luc
Brussels, 1200
Canada2 sites
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Italy2 sites
Policlinico Sant' Orsola - Malpighi
Bologna, 40138
Istituto Auxologico Italiano - Istituto Scientifico Ospedale San Luca
Milan, 20149
Netherlands1 site
Maastricht Universitair Medisch Centrum (MUMC)
Maastricht, 6229 HX
About this study
The purpose of this clinical study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.
Read the detailed description
The ECG Belt study is a prospective, interventional, randomized, multi-center, investigational, pre-market research study. The ECG Belt Research System will be used at implant and follow-up to help implanters choose a suitable LV pacing site within the recommended locations for LV lead implantation and optimize pacing vector/timing parameters.
- Conditions
- Heart Failure
- Being tested
- ECG Belt Research 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.
ECG Belt Research SystemDevice
The ECG Belt Research System is used to identify the best vector and programming parameters.
| Study group | Role | What they receive |
|---|---|---|
| ECG Belt | Experimental | The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits. Receives: Device: ECG Belt Research System |
| Control Arm | No intervention | Standard CRT through 6 months follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant.
Relative (%) change in LVESV from the baseline measurement to the 6 month measurement.
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start13 Jul 2018
- Primary completion7 Jan 2022
- Study completion20 Apr 2022
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 (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ECG Belt for CRT Response Clinical Research Specialist, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504020
- Sponsor's protocol ID
- ECG Belt for CRT Response
- Status last verified
- Jan 2023
- First submitted
- 12 Apr 2018
- Last updated
- 3 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rickard J, Jackson K, Biffi M, Vernooy K, Bank A, Cerkvenik J, Ghosh S, Gold MR. The ECG Belt for CRT response trial: Design and clinical protocol. Pacing Clin Electrophysiol. 2020 Oct;43(10):1063-1071. doi: 10.1111/pace.13985. Epub 2020 Sep 1.
PubMed 32537740Rickard J, Jackson K, Gold M, Biffi M, Ziacchi M, Silverstein J, Ramza B, Metzl M, Grubman E, Abben R, Varma N, Tabbal G, Jensen C, Wouters G, Ghosh S, Vernooy K; ECG Belt for CRT Response Study Group. Electrocardiogram Belt guidance for left ventricular lead placement and biventricular pacing optimization. Heart Rhythm. 2023 Apr;20(4):537-544. doi: 10.1016/j.hrthm.2022.11.015. Epub 2022 Nov 25.
PubMed 36442824
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECG Belt for CRT Response
- ClinicalTrials.gov ID
- NCT03504020
- Acronym / sponsor ID
- ECG Belt for CRT Response
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Posted 3 Feb 2023
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 study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.
Detailed description
The ECG Belt study is a prospective, interventional, randomized, multi-center, investigational, pre-market research study. The ECG Belt Research System will be used at implant and follow-up to help implanters choose a suitable LV pacing site within the recommended locations for LV lead implantation and optimize pacing vector/timing parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECG Belt | Experimental | Device: ECG Belt Research SystemThe ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits. |
| Control Arm | No intervention | –Standard CRT through 6 months follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indicated for CRT, with QRS duration ≥130 ms, and planned to be implanted with a market-released Medtronic CRT device with AdaptivCRT and a Medtronic quadripolar LV lead.
- Meets at least one of the following criteria: QRS duration < 150 ms, Prior documented Myocardial Infarction, Non-LBBB
- LVEDD ≥ 55 mm, as determined by site
Key exclusion criteria (8 listed)
- Permanent/persistent AF or presenting with AF
- Pre-existing or previous LV lead or other confounding devices e.g. Left Ventricular Assist Device, Vagal Nerve Stimulator
- Currently implanted with IPG or ICD with > 10% RV pacing
- Permanent complete AV block
- Enrolled in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent 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 |
|---|---|---|
| ECG Belt Research SystemThe ECG Belt Research System is used to identify the best vector and programming parameters. | Device | ECG Belt |
Primary outcome
Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant.
Time frame: baseline to 6 months
Relative (%) change in LVESV from the baseline measurement to the 6 month measurement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32537740Rickard J, Jackson K, Biffi M, Vernooy K, Bank A, Cerkvenik J, Ghosh S, Gold MR. The ECG Belt for CRT response trial: Design and clinical protocol. Pacing Clin Electrophysiol. 2020 Oct;43(10):1063-1071. doi: 10.1111/pace.13985. Epub 2020 Sep 1.
- Results publication: PubMed 36442824Rickard J, Jackson K, Gold M, Biffi M, Ziacchi M, Silverstein J, Ramza B, Metzl M, Grubman E, Abben R, Varma N, Tabbal G, Jensen C, Wouters G, Ghosh S, Vernooy K; ECG Belt for CRT Response Study Group. Electrocardiogram Belt guidance for left ventricular lead placement and biventricular pacing optimization. Heart Rhythm. 2023 Apr;20(4):537-544. doi: 10.1016/j.hrthm.2022.11.015. Epub 2022 Nov 25.
- Individual participant dataSharing planned: No
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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.
ECG Belt for CRT Response Clinical Research Specialist study chair
Medtronic
43 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG Belt Research System in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 43 sites in 7 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 3 inclusion and 8 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 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Belgium, Canada, Italy, Denmark and 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2023). 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?
Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant. (time frame: baseline to 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 NCT03504020, which also lists 2 linked publications.
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 3 Feb 2023.