Heart Failure, Systolic
Conditions
Keywords
Cardiac Resynchronization Therapy, Pacing, Echocardiography, Electrocardiography, Optimization, Heart Failure
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.
Interventions
DEVICEReprogramming of CRT Device Settings to Optimal Electrical Synchrony
Reprogramming of CRT device to maximize the benefit based on the ECG CRT optimization information.
Sponsors
Allina Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Intervention model description
1:1 randomization - active comparator and experimental arm (note: at 6 months the control arm will crossover)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactChristopher D Brown
Outcome results
None listed