ECG Belt vs. Echocardiographic Optimization of CRT
Completed · Not applicable
Conditions studied: Heart Failure, Systolic
In brief
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.
Key facts
- Study ID
- NCT03305692
- Run by
- Alan J. Bank, MD
- People needed
- 3
- Starts
- 2017-10-31
- Expected to finish
- 2021-08-17
- Last updated by the study team
- 2021-09-27
Who can join
Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- United Heart & Vascular Clinic — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
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