Skip to main content
. Author manuscript; available in PMC: 2015 Apr 1.
Published in final edited form as: JACC Cardiovasc Imaging. 2012 Jan;5(1):93–110. doi: 10.1016/j.jcmg.2011.11.006

Table 1.

Landmark CRT Trials

Study n Inclusion Criteria QRS (ms) Design Blinding Control Intervention Follow-Up
(months)
Primary End Point Results
MIRACLE (4) 453 NYHA functional class III
 or IV, LVEF ≤ 35%,
 LVEDD ≥ 55 mm, SR
≥130 Parallel Double
 blind
CRT-Off CRT-On 6 6MWD, NYHA functional
 class, MLHFQ score
↑ 6MWD (p = 0.005), improved
 NYHA functional class (p < 0.001),
 ↓ MLHFQ score (p = 0.001)
MIRACLE-ICD (5) 369 NYHA functional class III
 or IV, LVEF ≤ 35%,
 LVEDD ≥ 55 mm,
 ICD indicated, SR
≥130 Parallel Double
 blind
CRT-D
 (CRT-Off)
CRT-D (CRT-On) 6 Peak VO2, NYHA
 class, MLHFQ score
↑ 6MWD (p = 0.36), improved
 NYHA functional class (p = 0.007),
 ↓ MLHFQ score (p = 0.02)
Contak CD (6) 490 NYHA functional class
 II–IV, LVEF ≤ 35%,
 ICD indicated, SR
≥120 Parallel Double
 blind
CRT-D
 (CRT-Off)
CRT-D (CRT-On) 6 Composite: all-cause mortality,
 HF hospitalization, VT/VF
 requiring intervention
RRR 15% (p = 0.35)
COMPANION (1) 1,520 NYHA functional class III
 or IV, LVEF ≤ 35%,
 LVEDD ≥ 60 mm, SR
≥120 1:2:2 Medical
 therapy
CRT-P, CRT-D 16.2 (median) All-cause mortality or
 hospitalization
CRT-P HR: 0.81 (95% CI: 0.69−0.96;
 p = 0.014); CRT-D HR: 0.80
 (95% CI: 0.68–0.95; p = 0.010)
CARE-HF (3) 813 NYHA functional
 class III or IV, LVEF ≤
 35%, SR
≥150, 120−150 +
 echocardiographic
 dyssynchrony
Parallel Medical
 therapy
CRT-P 29.4 (mean) All-cause mortality or CV
 hospitalization
HR: 0.63 (95% CI: 0.51−0.77;
 p < 0.001)
CARE-HF
 Extended (2)
37.4 All-cause mortality HR: 0.60 (95% CI: 0.47−0.77;
 p < 0.0001)

CARE-HF = Cardiac Resynchronization–Heart Failure; CI = confidence interval; COMPANION = Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure; CRT = cardiac resynchronization therapy; CRT-D = cardiac resynchronization therapy with defibrillator; CRT-P = cardiac resynchronization therapy only; HF = heart failure; HR = hazard ratio; ICD = implantable cardioverter-defibrillator; LVEDD = left ventricular end-diastolic dimension; LVEF = left ventricular ejection fraction; MIRACLE = Multicenter InSync Randomized Clinical Evaluation; MIRACLE-ICD = Multicenter InSync ICD Randomized Clinical Evaluation; MLHFQ = Minnesota Living With Heart Failure Questionnaire; NYHA = New York Heart Association; RRR = relative risk ratio; 6MWD = 6-minute walk distance; SR = sinus rhythm; VF = ventricular fibrillation; VO2 = oxygen consumption; VT = ventricular tachycardia; ↑ = increased; ↓ = decreased.