ECG Belt vs. Echocardiographic Optimization of CRT

NCT ID: NCT03305692

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-31
• Study Completion Date: 2021-08-17

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.

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.

Conditions

Heart Failure, Systolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ECG Belt

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

Group Type: EXPERIMENTAL

Optimization of CRT Device

Intervention Type: 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.

Echocardiography

Use mitral inflow echocardiography to optimize CRT programming.

Group Type: EXPERIMENTAL

Optimization of CRT Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Alan J. Bank, MD

OTHER

Sponsor Role: lead

Responsible Party

Alan J. Bank, MD

Medical Director of Research - United Heart & Vascular Clinic

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alan Bank, MD

Role: PRINCIPAL_INVESTIGATOR

United Heart & Vascular Clinic - Allina Health System

Locations

United Heart & Vascular Clinic

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

ERP 3890

Identifier Type: -

Identifier Source: org_study_id