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

Heart Failure, Systolic Clinical Trial

— METEOR-CRT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04083690
• Other study ID #: IRBnet#: 1455594
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2019
• Est. completion date: October 1, 2024

Study information

• Verified date: June 2022
• Source: Allina Health System
• Contact: Christopher D Brown
• Phone: 651-241-2806
• Email: christopher.brown2[@]allina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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%

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

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.

Locations

Country	Name	City	State
United States	Minneapolis Heart Institute (Abbott Northwestern Hospital)	Minneapolis	Minnesota
United States	United Heart & Vascular Clinic	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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