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

Primary Purpose

Heart Failure, Systolic

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Reprogramming of CRT Device Settings to Optimal Electrical Synchrony

About this trial

This is an interventional treatment trial for Heart Failure, Systolic focused on measuring Cardiac Resynchronization Therapy, Pacing, Echocardiography, Electrocardiography, Optimization, Heart Failure

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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%

Sites / Locations

Minneapolis Heart Institute (Abbott Northwestern Hospital)Recruiting
United Heart & Vascular ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard CRT Programming, then ECG CRT Optimization

ECG CRT Optimization

Arm Description

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

The experimental arm patients will have CRT device reprogrammed based on the ECG CRT optimization information for 12 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in left ventricular function

Change left ventricular ejection fraction (EF), measured by echocardiogram, in patients in the experimental arm vs active comparator arm

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

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

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

Full Information

NCT ID

NCT04083690

First Posted

August 30, 2019

Last Updated

June 8, 2022

Sponsor

Allina Health System

1. Study Identification

Unique Protocol Identification Number

NCT04083690

Brief Title

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

Acronym

METEOR-CRT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 11, 2019 (Actual)

Primary Completion Date

October 1, 2023 (Anticipated)

Study Completion Date

October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Allina Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Systolic

Keywords

Cardiac Resynchronization Therapy, Pacing, Echocardiography, Electrocardiography, Optimization, Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantOutcomes 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.

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard CRT Programming, then ECG CRT Optimization

Arm Type

Active Comparator

Arm Description

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

Arm Title

ECG CRT Optimization

Arm Type

Experimental

Arm Description

The experimental arm patients will have CRT device reprogrammed based on the ECG CRT optimization information for 12 months.

Intervention Type

Device

Intervention Name(s)

Reprogramming of CRT Device Settings to Optimal Electrical Synchrony

Intervention Description

Reprogramming of CRT device to maximize the benefit based on the ECG CRT optimization information.

Primary Outcome Measure Information:

Title

Change in left ventricular size

Description

Change in left ventricular end-systolic volume (LVESV), measured by echocardiogram, in patients in the experimental arm vs active comparator arm

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change in left ventricular function

Description

Change left ventricular ejection fraction (EF), measured by echocardiogram, in patients in the experimental arm vs active comparator arm

Time Frame

6 months

Title

Change in left ventricular size

Description

Time Frame

6 months

Title

Change in left ventricular size

Description

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

Time Frame

6 months

Title

Change in left ventricular size

Description

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

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Correlation of change in electrical dyssynchrony and LVESV

Description

Changes in electrical dyssynchrony, as measured by electrocardiography (ECG) and correlation to change LVESV, measured by echocardiogram, in the entire patient cohort

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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%

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christopher D Brown

Phone

651-241-2806

christopher.brown2@allina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan J Bank, MD

Organizational Affiliation

United Heart & Vascular - Allina Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Minneapolis Heart Institute (Abbott Northwestern Hospital)

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter M Eckman, MD

Phone

612-863-9000

peter.eckman@allina.com

First Name & Middle Initial & Last Name & Degree

Christopher D Brown

Phone

651-241-2806

christopher.brown2@allina.com

First Name & Middle Initial & Last Name & Degree

Alan J Bank, MD

First Name & Middle Initial & Last Name & Degree

Peter M Eckman, MD

Facility Name

United Heart & Vascular Clinic

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55102

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christopher D Brown, BA

Phone

651-241-2806

christopher.brown2@allina.com

First Name & Middle Initial & Last Name & Degree

Alan J Bank, MD

First Name & Middle Initial & Last Name & Degree

Peter M Eckman, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We do not plan to share IPD with other researchers

Learn more about this trial

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

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