Optimizing CRT With ECGI

Last updated: April 29, 2019
Sponsor: Washington University School of Medicine
Overall Status: Terminated

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Heart Failure

Treatment

N/A

Clinical Study ID

NCT03492788
201712146
  • Ages 18-100
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥18 years of age who are able to give consent, having systolic heart failuredespite treatment with guideline directed medical therapy, undergoing successful CRTdevice implant for standard clinical indications, expected to have over 95% heartbeats resynchronized by the pacing device (absence of competing arrhythmias), and haveRV or LV pacing latency (stimulus to rapid QRS deflection) ≥30 msec

Exclusion

Exclusion Criteria:

  • Patients unable to comply with the study follow-up, life expectancy ≤1 year,suboptimal LV lead location (septal or apical)

Study Design

Total Participants: 3
Study Start date:
December 28, 2017
Estimated Completion Date:
October 05, 2018

Study Description

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.

Connect with a study center

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

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