Status:
COMPLETED
ECG Belt vs. Echocardiographic Optimization of CRT
Lead Sponsor:
Alan J. Bank, MD
Collaborating Sponsors:
Medtronic
Conditions:
Heart Failure, Systolic
Eligibility:
All Genders
18-110 years
Phase:
NA
Brief 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 ...
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 f...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03305692
Start Date
October 31 2017
End Date
August 17 2021
Last Update
September 27 2021
Active Locations (1)
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1
United Heart & Vascular Clinic
Saint Paul, Minnesota, United States, 55102