ECG Belt vs. Echocardiographic Optimization of CRT

NCT03305692 | Completed FDA Device

• 1 other identifier: ERP 3890
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Systolic

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Echocardiographic assessment of LV function

  Change in ejection fraction

  6 months post optimization

• Echocardiographic assessment of LV size

  Change in left ventricular end-systolic volume

  6 months post optimization

Study Arms (2)

ECG Belt

EXPERIMENTAL

Use ECG Belt body surface mapping system to optimize CRT programming.

Diagnostic Test: Optimization of CRT Device

Echocardiography

EXPERIMENTAL

Use mitral inflow echocardiography to optimize CRT programming.

Diagnostic Test: Optimization of CRT Device

Interventions

Optimization of CRT Device DIAGNOSTIC_TEST

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.

ECG Belt; Echocardiography

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Alan J. Bank, MD: lead
• Medtronic: collaborator

Study Sites (1)

United Heart & Vascular Clinic

Saint Paul, Minnesota, 55102, United States

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Alan Bank, MD

  United Heart & Vascular Clinic - Allina Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individual analyzing echocardiograms (primary outcome) will not know randomization of the subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director of Research - United Heart & Vascular Clinic

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 10, 2017
• Study Start: October 31, 2017
• Primary Completion: August 17, 2021
• Study Completion: August 17, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)