Table 5. Description of studies included in the efficacy review: CRT for CHF

Number of Participants
Study nameCountryDesignControl armTotal enrolledExclusionsTotal randomizedTreatment*Control*WithdrawalsDeviceAuthors' primary outcome(s)Other outcomes
DurationMethod of implant
Abraham 2002 MIRACLE61 U.S. and CanadaRCT parallelPacer “Inactive”5714453228225Treatment 1InSync model 8040 MedtronicNYHA class; QOL, 6MWTPeak O2 consumption; time on a treadmill; LVEF; LVEDD; severity of mitral regurgitation; duration of QRS interval; clinical composite response (improved, worsened, unchanged); death; worsening heart failure; number of days spent in hospital
6 mo.Control 8Transvenous
Auricchio 2002 PATH-CHF62 Germany, NetherlandsRCT X-overUni-ventricular pacing (4 right, 36 left)421412417Treatment 2Vigor / Discovery with LV lead GuidantO2 uptake at peak exercise; O2 uptake at anaerobic threshold; 6MWTNYHA; QOL
1 mo.Control 5Transthoracic
Bristow 2003 COMPANION60 U.S. multicenterRCT parallel 3 armsOPT--1520CRT=617308-CONTAK TR Models 4510–4513, Model 1241 CONTAK CD Model 1823 Guidant.CRT: all-cause mortality & hospitalization. CRT-ICD: all-cause mortality & hospitalizationCardiac morbidity; ADRs, implant success; peak O2 uptake at exercise
12 mo.CRT-D=595Transvenous
Cazeau 200174 MUSTIC-SREurope (15 sites)RCT X-overPacer “Inactive”673582929Treatment 4Chorum 7336 ELA Medical or InSync 8040 Medtronic6MWTQOL (main secondary outcome); peak O2 uptake; hospital admissions because of decompensated heart failure; patient's preference with regard to pacing (active vs. inactive) at the end of crossover; death
3 mo.Control 3Transvenous
Garrigue 200270 FranceRCT X-overLeft ventricular pacing-013670Model 2188 MedtronicClinical and hemodynamic variablesHemodynamic changes during exercise
2 mo.Transvenous
Guidant 2002 CONTAK-CD73 FDA ReportU.S. (47 sites)RCTPacer “Inactive”58115490245245Treatment 3CONTAK-CDAll-cause mortality; CHF hospitalizations; ventricular tachyarrhythmia requiring device interventionPeak O2 consumption; QOL; 6MWT, all adverse events
Phase I period 1 of X-over 3 moControl 1Transvenous and Transthoracic
Phase II parallel 6 mo.
Leclercq 2002 MUSTIC-AF75 Europe (15 sites)RCT X-overRight ventricular pacing6410432518Treatment 1ELA medical, Medtronic6MWTPeak O2 consumption; QOL; hospital admissions for decompensated heart failure; mortality; patient's preferred period at end of crossover
3 mo.Control 2Transvenous
Both 2
Leclercq 2003 RD-CHF** UnpublishedFranceRCT X-overRight ventricular pacing56Unclear442222UnclearTransvenousCHF hospitalizationN/a
3 mo.
Medtronic 2001 MIRACLE-ICD36 FDA reportU.S. and Canada (53 sites)RCT (post implant) parallelPacer “Inactive”659105554272282Treatment 7Model 7272 InSync ICD, Attain LV leads models 4189, 2187, 2188.NYHA; QOL; 6MWT;ADRs; QRS; peak O2 uptake; echocardiographic indices; LV lead electrical performance; VT/VF therapy; CHF composite response; implant ventricular defibrillation criterion; ATP therapy; healthcare utilization; death
6 mo.Control 6Transvenous

ADR = adverse reaction; CRT = cardiac resynchronization therapy; CRT ICD = CRT with implanted cardioverter defibrillator; FDA = Food and Drug Administration; LVEF = left ventricular ejection fraction; LVEDD = left ventricular end diastolic diameter; N/a = not available; NYHA = New York Heart Association class; QOL = quality of life; OPT = optimal pharmacological therapy; RCT = randomized control trial; 6MWT = 6-minute walk test; X-over = crossover study

*

the intervention that crossover studies received in the first period

**

detailed data not available for Leclercq 2003 (RD-CHF) at the time this report was prepared

t

excludes deaths and implant failures, where applicable

Note: While the published report for MIRACLE-ICD was used for patients with NYHA Class III or IV symptoms, the FDA report was used for NYHA Class II patients as they were not included in the published MIRACLE-ICD manuscript

From: 3, Results

Cover of Cardiac Resynchronization Therapy for Congestive Heart Failure
Cardiac Resynchronization Therapy for Congestive Heart Failure.
Evidence Reports/Technology Assessments, No. 106.
McAlister F, Ezekowitz J, Wiebe N, et al.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.