ECG Belt vs. Echocardiographic Optimization of CRT

Heart Failure, Systolic Clinical Trial

Official title:

Optimization of New CRT Recipients: Subjects Randomized to ECG Belt or Echocardiographic Optimization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305692
• Other study ID #: ERP 3890
• Status: Completed
• Phase: N/A
• Start date: October 31, 2017
• Est. completion date: August 17, 2021

Study information

• Verified date: September 2021
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 17, 2021
• Est. primary completion date: August 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

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.

Locations

Country	Name	City	State
United States	United Heart & Vascular Clinic	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Alan J. Bank, MD	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiographic assessment of LV function	Change in ejection fraction	6 months post optimization
Primary	Echocardiographic assessment of LV size	Change in left ventricular end-systolic volume	6 months post optimization