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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-11

Study Completion Date

2024-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of CRT Optimization as Assessed by Cardiac MR

NCT04763460

Heart Failure, Systolic

UNKNOWN NA

Stimulus Intensity in Left Ventricular Leads

NCT01060449

Congestive Heart Failure

COMPLETED NA

Optimizing CRT With ECGI

NCT03492788

Heart Failure, Systolic Left Bundle-Branch Block

TERMINATED NA

Cardiac Resynchronization Therapy (CRT) and Left Ventricular Assist Devices (LVAD) Therapy

NCT02083419

Heart Failure

COMPLETED

ECG Belt vs. Echocardiographic Optimization of CRT

NCT03305692

Heart Failure, Systolic

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure, Systolic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Reprogramming of CRT Device Settings to Optimal Electrical Synchrony

Intervention Type DEVICE

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

ECG CRT Optimization

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

Group Type EXPERIMENTAL

Reprogramming of CRT Device Settings to Optimal Electrical Synchrony

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Reprogramming of CRT Device Settings to Optimal Electrical Synchrony

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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%

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No