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Study Design. Patients qualifying for CRT. Responders. Patients with LBBB and LV dysfunction. Patients with Narrow / Normal QRS. 0. 100. Study Design. Overall Objective
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Study Design Patients qualifying for CRT Responders Patients with LBBB and LV dysfunction Patients with Narrow / Normal QRS 0 100
Study Design Overall Objective Determine CRT safety and efficacy in patients who are indicated for an ICD with NYHA Class III, narrow QRS duration (<130 ms) and evidence of mechanical dyssynchrony as measured by echocardiography/Tissue Doppler Imaging Primary Endpoint Improvement in Peak VO2 during CPET of at least 1.0ml/kg/min at 6 months. Secondary Endpoints Improvement in QoL score at 6-months Improvement in NYHA classification at 6-months
Efficacy Analysis/Study Flow A total of 156 (80 Control + 76 CRT) were available for efficacy analysis
Quality of Life % Improved in Peak VO2 Median & 95% Conf Int 100 70 p = 0.91 p = 0.63 80 60 60 46% 50 41% 40 40 20 30 0 Baseline 6-months Control CRT NYHA Class Six-minute Hall Walk Distance (m) Median & 95% Conf Int 100 p = 0.23 p = 0.006 80 400 64% 60 54% 350 41% 40 29% 20 300 8% 5% 0 Improved No Change Worsened Baseline 6-months 250 Control (n = 80) Control (n = 80) CRT (n = 76) CRT (n = 76) Efficacy Data
QRS Duration Cardiomyopathy Type 100 100 p = 0.45 p = 0.02 p = 0.82 p = 0.25 80 80 60 60 Peak VO2 (% improved from baseline) (% improved from baseline) 40 40 20 20 0 0 QRS < 120 ms QRS ≥ 120 ms Ischemic Non-ischemic Control (n = 80) CRT (n = 76) Peak VO2 by sub-group
Conclusion • In this randomized controlled trial, CRT did not improve Peak VO2 during exercise in patients with NYHA Class III heart failure, QRS duration <130ms, and an EF ≤ 35%. • However, the subgroup of patients with QRS duration between 120 ms and 130 ms benefited from CRT. • Additional research will be critical to further our understanding of the role of CRT in this patient population.