Heart Failure
Conditions
Brief 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.
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.
Interventions
DEVICEECG Belt Research System
The ECG Belt Research System is used to identify the best vector and programming parameters.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant. | baseline to 6 months | Relative (%) change in LVESV from the baseline measurement to the 6 month measurement. |
Countries
Belgium, Canada, Denmark, Italy, Netherlands, Switzerland, United States
Participant flow
Pre-assignment details
* 498 pts enrolled, 55 exits prior to randomization * 443 pts randomized, 35 pts not implanted
Participants by arm
| Arm | Count |
|---|---|
| ECG Belt The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.\>
\> ECG Belt Research System: The ECG Belt Research System is used to identify the best vector and programming parameters. | 200 |
| Control Arm Standard CRT through 6 months follow-up. | 208 |
| Total | 408 |
Baseline characteristics
| Characteristic | ECG Belt | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 10.4 | 67.8 years STANDARD_DEVIATION 10.1 | 68.8 years STANDARD_DEVIATION 10.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 44 Participants | 41 Participants | 85 Participants |
| Sex: Female, Male Male | 156 Participants | 167 Participants | 323 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 200 | 6 / 208 |
| other Total, other adverse events | 0 / 200 | 0 / 208 |
| serious Total, serious adverse events | 68 / 200 | 52 / 208 |
Outcome results
Primary
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.
Time frame: baseline to 6 months
Population: Patients were only included in the analysis if they completed the Baseline and 6-month visit. For some patients, if the 6-month visit was not available, but the 9-month visit was, then the 9-month visit was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ECG Belt | Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant. | -11.7 Percent Change | Standard Deviation 29 |
| Control Arm | Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant. | -14.7 Percent Change | Standard Deviation 29.6 |