N/A
Completed N=408
ECG Belt for CRT Response
Source: ClinicalTrials.gov NCT03504020 ↗Enrolled (actual)
408
Serious AEs
29.4%
Results posted
Feb 2023
Primary outcomePrimary: Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant. — -11.7; -14.7 Percent Change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricular End Systolic Volume (LVESV) From Baseline to 6 Months Post-implant. |
-11.7; -14.7 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT03504020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.