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

Sponsor

Allina Health System (Other)

Overall Status

Recruiting

CT.gov ID

NCT04083690

Collaborator

(none)

120

Enrollment

Locations

Arms

59.7

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Systolic	Device: Reprogramming of CRT Device Settings to Optimal Electrical Synchrony	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 randomization - active comparator and experimental arm (note: at 6 months the control arm will crossover)1:1 randomization - active comparator and experimental arm (note: at 6 months the control arm will crossover)

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Patients blinded to which study group they randomized and how their CRT device is programmed. Individuals (readers) who perform echocardiographic measurements blinded to patient randomization and CRT settings.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 11, 2019

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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 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 [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 [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

Other Outcome Measures

Correlation of change in electrical dyssynchrony and LVESV [12 months]
Changes in electrical dyssynchrony, as measured by electrocardiography (ECG) and correlation to change LVESV, measured by echocardiogram, in the entire patient cohort

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minneapolis Heart Institute (Abbott Northwestern Hospital)	Minneapolis	Minnesota	United States	55407
2	United Heart & Vascular Clinic	Saint Paul	Minnesota	United States	55102