Optimizing CRT With ECGI
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/17/2018 |
| Start Date: | December 28, 2017 |
| End Date: | December 31, 2019 |
| Contact: | Amit Noheria, MBBS, SM |
| Email: | anoheria@wustl.edu |
| Phone: | 3143621291 |
Optimizing Cardiac Resynchronization Therapy With Electrocardiographic Imaging
CRT is delivered from two electrodes on opposite sides of the heart [right (RV) and left
ventricle (LV)] delivering stimulation for more efficient heart beats. There is flexibility
in the sequence and temporal staggering of the stimulation from these two electrodes with a
different optimum for different patients. However, standard techniques to figure out the
optimal stimulation strategy like standard 12-lead surface electrical recording (ECG) or
routine ultrasound have failed. The investigators have developed ECG imaging (ECGI) with 250
electrode surface recording combined with CT scan to reconstruct high resolution
4-dimensional panoramic electrical maps of the heart. The study seeks to enroll 56 patients
undergoing CRT in a clinical trail to evaluate short and long term impact of using ECGI for
optimal programming of CRT.
ventricle (LV)] delivering stimulation for more efficient heart beats. There is flexibility
in the sequence and temporal staggering of the stimulation from these two electrodes with a
different optimum for different patients. However, standard techniques to figure out the
optimal stimulation strategy like standard 12-lead surface electrical recording (ECG) or
routine ultrasound have failed. The investigators have developed ECG imaging (ECGI) with 250
electrode surface recording combined with CT scan to reconstruct high resolution
4-dimensional panoramic electrical maps of the heart. The study seeks to enroll 56 patients
undergoing CRT in a clinical trail to evaluate short and long term impact of using ECGI for
optimal programming of CRT.
Heart failure (HF) with reduced ejection fraction is a major global health problem. Every
year, over 200,000 patients with HF and electrical abnormalities receive device implants for
Cardiac Resynchronization Therapy (CRT). However, one-third of these patients receiving CRT
fail to clinically improve, a large population with refractory HF symptoms, high mortality,
and tremendous healthcare costs. The overall objective of the study is to improve the
clinical response to CRT by physiological optimization of CRT programming with individualized
ventriculo-ventricular (VV) offset, guided by novel 4-dimensional panoramic electroanatomical
heart mapping using Electrocardiographic Imaging (ECGI). ECGI is a high-resolution,
non-invasive, validated technique using 250 recording electrodes combined with heart-torso
anatomy from chest CT.
Specific Aims:
1. Assess the acute impact of ECGI-guided CRT optimization on hemodynamic heart function.
2. Determine the impact of ECGI-guided CRT optimization on reverse heart remodeling at 6
months.
Methods:
The study will enroll 56 adult patients undergoing CRT for standard clinical indications.
1. Compare the impact of ECGI-guided CRT optimization vs. standard-of-care (zero VV offset)
on acute hemodynamic function i.e. left ventricular stroke volume on Doppler
echocardiography.
2. Randomize patients to (a) ECGI-guided CRT optimization or (b) standard-of-care (zero VV
offset). Patients will be crossed-over at 6 months and serve as their own controls. The
primary outcome will be the difference in heart remodeling, i.e. % reduction of left
ventricular end-systolic volume (LVESV) from baseline, between the two groups after 6
months. Reduction in LVESV is a validated physiological marker of CRT response that
strongly predicts lower mortality and HF events. The secondary outcomes will include
quality-of-life (Kansas City Cardiomyopathy Questionnaire), functional performance
(6-minute hall walk distance) and a prognostic biomarker (serum N-terminal proBNP).
The results of this important study will provide key mechanistic insights on the salutary
effects of CRT on reverse heart remodeling and enhance the understanding of failure in CRT
response. Physiologically tailored CRT therapy would improve individual patient health by
reducing CRT non-responders, and decrease the economic burden of refractory HF.
year, over 200,000 patients with HF and electrical abnormalities receive device implants for
Cardiac Resynchronization Therapy (CRT). However, one-third of these patients receiving CRT
fail to clinically improve, a large population with refractory HF symptoms, high mortality,
and tremendous healthcare costs. The overall objective of the study is to improve the
clinical response to CRT by physiological optimization of CRT programming with individualized
ventriculo-ventricular (VV) offset, guided by novel 4-dimensional panoramic electroanatomical
heart mapping using Electrocardiographic Imaging (ECGI). ECGI is a high-resolution,
non-invasive, validated technique using 250 recording electrodes combined with heart-torso
anatomy from chest CT.
Specific Aims:
1. Assess the acute impact of ECGI-guided CRT optimization on hemodynamic heart function.
2. Determine the impact of ECGI-guided CRT optimization on reverse heart remodeling at 6
months.
Methods:
The study will enroll 56 adult patients undergoing CRT for standard clinical indications.
1. Compare the impact of ECGI-guided CRT optimization vs. standard-of-care (zero VV offset)
on acute hemodynamic function i.e. left ventricular stroke volume on Doppler
echocardiography.
2. Randomize patients to (a) ECGI-guided CRT optimization or (b) standard-of-care (zero VV
offset). Patients will be crossed-over at 6 months and serve as their own controls. The
primary outcome will be the difference in heart remodeling, i.e. % reduction of left
ventricular end-systolic volume (LVESV) from baseline, between the two groups after 6
months. Reduction in LVESV is a validated physiological marker of CRT response that
strongly predicts lower mortality and HF events. The secondary outcomes will include
quality-of-life (Kansas City Cardiomyopathy Questionnaire), functional performance
(6-minute hall walk distance) and a prognostic biomarker (serum N-terminal proBNP).
The results of this important study will provide key mechanistic insights on the salutary
effects of CRT on reverse heart remodeling and enhance the understanding of failure in CRT
response. Physiologically tailored CRT therapy would improve individual patient health by
reducing CRT non-responders, and decrease the economic burden of refractory HF.
Inclusion Criteria:
- Patients ≥18 years of age who are able to give consent, having systolic heart failure
despite treatment with guideline directed medical therapy, undergoing successful CRT
device implant for standard clinical indications, expected to have over 95% heart
beats resynchronized by the pacing device (absence of competing arrhythmias), and have
RV or LV pacing latency (stimulus to rapid QRS deflection) ≥30 msec
Exclusion Criteria:
- Patients unable to comply with the study follow-up, life expectancy ≤1 year,
suboptimal LV lead location (septal or apical)
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Amit Noheria, MBBS, SM
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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