ECG Belt vs. Echocardiographic Optimization of CRT
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ClinicalTrials.gov Identifier: NCT03305692 |
Recruitment Status :
Completed
First Posted : October 10, 2017
Last Update Posted : September 27, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure, Systolic | Diagnostic Test: Optimization of CRT Device | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 1:1 randomization |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Individual analyzing echocardiograms (primary outcome) will not know randomization of the subject. |
Primary Purpose: | Treatment |
Official Title: | Optimization of New CRT Recipients: Subjects Randomized to ECG Belt or Echocardiographic Optimization |
Actual Study Start Date : | October 31, 2017 |
Actual Primary Completion Date : | August 17, 2021 |
Actual Study Completion Date : | August 17, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: ECG Belt
Use ECG Belt body surface mapping system to optimize CRT programming.
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Diagnostic Test: Optimization of CRT Device
Use a body surface mapping system to quantify electrical dyssynchrony or echocardiography to quantify diastolic blood flow characteristics. Program the pacemaker to maximize the benefit of the modality the subject is randomized to. |
Experimental: Echocardiography
Use mitral inflow echocardiography to optimize CRT programming.
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Diagnostic Test: Optimization of CRT Device
Use a body surface mapping system to quantify electrical dyssynchrony or echocardiography to quantify diastolic blood flow characteristics. Program the pacemaker to maximize the benefit of the modality the subject is randomized to. |
- Echocardiographic assessment of LV function [ Time Frame: 6 months post optimization ]Change in ejection fraction
- Echocardiographic assessment of LV size [ Time Frame: 6 months post optimization ]Change in left ventricular end-systolic volume

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Ages Eligible for Study: | 18 Years to 110 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305692
United States, Minnesota | |
United Heart & Vascular Clinic | |
Saint Paul, Minnesota, United States, 55102 |
Principal Investigator: | Alan Bank, MD | United Heart & Vascular Clinic - Allina Health System |
Responsible Party: | Alan J. Bank, MD, Medical Director of Research - United Heart & Vascular Clinic, Allina Health System |
ClinicalTrials.gov Identifier: | NCT03305692 |
Other Study ID Numbers: |
ERP 3890 |
First Posted: | October 10, 2017 Key Record Dates |
Last Update Posted: | September 27, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | We do not plan to share IPD with other researchers. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
cardiac resynchronization therapy pacing echocardiography optimization heart failure |
Heart Failure Heart Failure, Systolic Heart Diseases Cardiovascular Diseases |