Multi-lead ECG to Effectively Optimize Resynchronization Devices: New CRT Recipients

Not Applicable

Recruiting

• Conditions: Heart Failure, Systolic
• Interventions: Device: Reprogramming of CRT Device Settings to Optimal Electrical Synchrony

• Registration Number: NCT04083690
• Lead Sponsor: Allina Health System

Brief Summary

Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical dyssynchrony. A traditional CRT device has pacing leads implanted within the right atrium (RA), the right ventricle (RV), and within a coronary vein overlying the lateral or posterior left ventricle (LV). Within the past decade, various multi-center randomized controlled trials have reported improved quality of life, aerobic exercise capacity, LV systolic function and structure, as well as decreased hospitalization rates and mortality among patients with HF. Despite improvements in CRT technology with multipoint pacing, quadripolar leads, and adaptive pacing algorithms, approximately 30% of patients do not clinically benefit and are considered non-responders. This study looks to optimize new CRT device recipients using information obtained from standard ECG machines.

Detailed Description

This is a prospective, randomized study designed to evaluate if CRT device optimization, guided by electrocardiography, improves echocardiographic and clinical outcomes among HF patients with a CRT device implanted for standard indications. All patients will have measurement of electrocardiograms at a range of device settings. Patients will be randomized in a 1:1 ratio to either the active comparator arm (standard CRT programming), or the experimental arm (CRT device programmed by the information obtained by ECGs). Standard CRT programming used in this study is simultaneous biventricular (BiV) pacing with a fixed atrioventricular delay. At 6 months, control patients who were initially randomized to standard programming will have programming changed based on the ECG optimization information. Patients will be blinded to randomization. Change of LV size and function will be performed prior to randomization, and again \~6 and \~12 months following CRT implant in both subgroups.

Study Timeline

• Study First Submitted: 2019-08-30
• Study First Submitted QC: 2019-09-06
• Study First Posted: 2019-09-10
• Study Start: 2019-10-11
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-09
• Primary Completion: 2023-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Patients (or their legal guardian) must be willing to provide informed consent and sign a data privacy authorization (HIPAA) form
2. Age greater than or equal 18 years
3. Pre-CRT EF less than or equal 40%
4. Patients will be receiving or have received a first-time CRT device for standard clinical indications within ~2 months of study enrollment
5. Adequate echocardiographic images for LV EF and LV ESV determination
6. On optimal medical therapy

Exclusion Criteria

1. Patients who are pregnant or may become pregnant
2. Patient has a history of severe allergic reactions from ECG gel/ electrode adhesives
3. Patient has a His Bundle pacing lead
4. Patient has right bundle branch block (RBBB)
5. Patient is enrolled in concurrent research study that would potentially confound the results of this study
6. Premature ventricular contraction (PVC) burden greater than or equal to 10%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECG CRT Optimization	Reprogramming of CRT Device Settings to Optimal Electrical Synchrony	The experimental arm patients will have CRT device reprogrammed based on the ECG CRT optimization information for 12 months.
Standard CRT Programming, then ECG CRT Optimization	Reprogramming of CRT Device Settings to Optimal Electrical Synchrony	The control arm patients will have standard CRT programming for the first 6 months, and then will be reprogrammed based on the ECG CRT optimization information for the following 6 months

Primary Outcome Measures

Name	Time	Method
Change in left ventricular size	6 months	Change in left ventricular end-systolic volume (LVESV), measured by echocardiogram, in patients in the experimental arm vs active comparator arm

Secondary Outcome Measures

Name	Time	Method
Change in left ventricular function	6 months	Change left ventricular ejection fraction (EF), measured by echocardiogram, in patients in the experimental arm vs active comparator arm
Change in left ventricular size	6 months	Change in LVESV, measured by echocardiogram, in patients in the active comparator arm (crossed-over to optimization device settings at 6 months) at 12 months vs 6 months

Trial Locations

Locations (2)

United Heart & Vascular Clinic; 🇺🇸 Saint Paul, Minnesota, United States

Minneapolis Heart Institute (Abbott Northwestern Hospital); 🇺🇸 Minneapolis, Minnesota, United States