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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 1, 2023

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.

Interventions

  • Device: Reprogramming of CRT Device Settings to Optimal Electrical Synchrony
    • Reprogramming of CRT device to maximize the benefit based on the ECG CRT optimization information.

Arms, Groups and Cohorts

  • Active Comparator: Standard CRT Programming, then ECG CRT Optimization
    • 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
  • Experimental: ECG CRT Optimization
    • The experimental arm patients will have CRT device reprogrammed based on the ECG CRT optimization information for 12 months.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change in left ventricular function
    • Time Frame: 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
    • Time Frame: 6 months
    • Change in LVESV, measured by echocardiogram, in the subset of patients with left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) in the experimental arm vs the active comparator arm
  • Change in left ventricular size
    • Time Frame: 6 months
    • Change in LVESV, measured by echocardiogram, in the subset of patients with complete heart block (CHB) or persistent atrial fibrillation (AF) in the experimental arm vs the active comparator arm
  • Change in left ventricular size
    • Time Frame: 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

Participating in This Clinical Trial

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%

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Allina Health System
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alan J. Bank, MD, Medical Director of Research – United Heart & Vascular Clinic – Allina Health System
  • Overall Official(s)
    • Alan J Bank, MD, Principal Investigator, United Heart & Vascular – Allina Health System
  • Overall Contact(s)
    • Christopher D Brown, 651-241-2806, christopher.brown2@allina.com

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