ECG Belt vs. Echocardiographic Optimization of CRT

• ClinicalTrials.gov Identifier: NCT03305692
• Recruitment Status: Completed
• First Posted: October 10, 2017
• Last Update Posted: September 27, 2021
• Sponsor: Alan J. Bank, MD
• Collaborator: Medtronic
• Information provided by (Responsible Party): Alan J. Bank, MD, Allina Health System

Study Description

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 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.

Condition or disease	Intervention/treatment	Phase
Heart Failure, Systolic	Diagnostic Test: Optimization of CRT Device	Not Applicable

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 functional outcomes in heart failure (HF) patients. The population will include patients treated with CRT for standard indications (not implanted for the sole purposes of this study). The study will focus enrollment on patients who do not have baseline characteristics predicting the best CRT response. Therefore the study will not enroll patients having non-ischemic HF etiology, left bundle branch (LBBB) morphology, and QRSd > 150 ms or those previously RV paced.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: ECG Belt; Use ECG Belt body surface mapping system to optimize CRT programming.	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.	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.

Outcome Measures

Primary Outcome Measures :

1. Echocardiographic assessment of LV function [ Time Frame: 6 months post optimization ]
   Change in ejection fraction
2. Echocardiographic assessment of LV size [ Time Frame: 6 months post optimization ]
   Change in left ventricular end-systolic volume

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Minnesota

United Heart & Vascular Clinic

Saint Paul, Minnesota, United States, 55102

Sponsors and Collaborators

Alan J. Bank, MD

Medtronic

Investigators

• Principal Investigator: Alan Bank, MD; United Heart & Vascular Clinic - Allina Health System

More Information

• 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
• 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

Keywords provided by Alan J. Bank, MD, Allina Health System:

cardiac resynchronization therapy; pacing; echocardiography; optimization; heart failure

Additional relevant MeSH terms:

Heart Failure; Heart Failure, Systolic; Heart Diseases; Cardiovascular Diseases