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

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 Overview

• Status: Recruiting
• Conditions: Heart Failure, Systolic
• Intervention / Treatment: Device: Reprogramming of CRT Device Settings to Optimal Electrical Synchrony

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher D Brown; Phone Number: 651-241-2806; Email: christopher.brown2@allina.com

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Minneapolis Heart Institute (Abbott Northwestern Hospital)
      • Contact: Christopher D Brown; Phone Number: 651-241-2806; Email: christopher.brown2@allina.com
      • Principal Investigator: Alan J Bank, MD
      • Contact: Peter M Eckman, MD; Phone Number: 612-863-9000; Email: peter.eckman@allina.com
      • Sub-Investigator: Peter M Eckman, MD
    • Saint Paul, Minnesota, United States, 55102
      • Recruiting
      • United Heart & Vascular Clinic
      • Principal Investigator: Alan J Bank, MD
      • Sub-Investigator: Peter M Eckman, MD
      • Contact: Christopher D Brown, BA; Phone Number: 651-241-2806; Email: christopher.brown2@allina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.
EXPERIMENTAL: ECG CRT Optimization; The experimental arm patients will have CRT device reprogrammed based on the ECG CRT optimization information for 12 months.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in left ventricular function	Change left ventricular ejection fraction (EF), measured by echocardiogram, in patients in the experimental arm vs active comparator arm	6 months
Change in left ventricular size	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	6 months
Change in left ventricular size	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	6 months
Change in left ventricular size	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	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of change in electrical dyssynchrony and LVESV	Changes in electrical dyssynchrony, as measured by electrocardiography (ECG) and correlation to change LVESV, measured by echocardiogram, in the entire patient cohort	12 months

Collaborators and Investigators

• Sponsor: Allina Health System
• Investigators: Principal Investigator: Alan J Bank, MD, United Heart & Vascular - Allina Health System

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 11, 2019
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): October 1, 2024

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (ACTUAL): September 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiac Resynchronization Therapy; Echocardiography; Optimization; Electrocardiography; Pacing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Systolic
• Other Study ID Numbers: IRBnet#: 1455594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share IPD with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No