Assessment of cardiac resynchronisation therapy in patients with wide QRS and non-specific intraventricular conduction delay: rationale and design of the multicentre randomised NICD-CRT study.
Cardiac resynchronisation therapy (CRT) was initially developed to treat patients with left bundle branch block (LBBB). However, many patients with heart failure have a widened QRS but neither left-BBB nor right-BBB; this is called non-specific intraventricular conduction delay (NICD). It is unclear whether CRT is effective in this subgroup of patients.



The NICD-CRT study is a prospective, double-blind, randomised (1:1), parallel-arm, multicentre trial comparing the effects of CRT in patients with heart failure, a reduced left ventricular ejection fraction (LVEF <35%) and NICD, who have been implanted with a device (CRT-pacemaker or CRT-defibrillator) that has or has not been activated. Enrolment began on 15 July 2015 and should finish within 3 years; 40 patients have already been randomised and 11 centres have agreed to participate. The primary end point is the comparison of the proportion of patients improved, unchanged or worsened over the subsequent 12 months. 100 patients per group are required to demonstrate a difference between groups with a statistical power of 90%, a type I error of 0.05% (two-sided) and a loss to follow-up of 10%. This trial will add substantially to the modest amount of existing data on CRT in patients with NICD and should reduce uncertainty for guidelines and clinical practice when added to the pool of current information.



Local ethics committee authorisations have been obtained since May 2015. We will publish findings from this study in a peer-reviewed scientific journal and present results at national and international conferences.



NCT02454439; pre-results.
Cardiology Department, Clermont Université, Université d'Auvergne, Cardio Vascular Interventional Therapy and Imaging (CaVITI), Image Science for Interventional Techniques (ISIT), UMR6284, and CHU Clermont-Ferrand, Clermont-Ferrand, France.
Romain
R
Eschalier
Hôpital Cardiologique du Haut-Lévêque, CHU Bordeaux, Université Bordeaux, IHU LIRYC, Bordeaux, France.
Sylvain
S
Ploux
CHU Clermont-Ferrand, Biostatistics unit (Clinical Research and Innovation Direction), Clermont-Ferrand, France.
Bruno
B
Pereira
Cardiology Department, Trousseau Hospital, François-Rabelais University, Tours, France.
Nicolas
N
Clémenty
North Hospital, Saint-Etienne, France.
Antoine
A
Da Costa
Arrhythmia Unit, Cardiology Department, University Hospital, Grenoble, France.
Pascal
P
Defaye
Cardiology Department, Saint-Augustin Clinic, Bordeaux, France.
Stéphane
S
Garrigue
Cardiology Department, PHU2, Nantes University Hospital, Saint Herblain, France.
Jean-Baptiste
JB
Gourraud
Nouvelles Cliniques Nantaises, Nantes, France.
Daniel
D
Gras
Cardiology Department, Limoges University Hospital, Limoges, France.
Benoît
B
Guy-Moyat
Department of Cardiology and Vascular Disease, Pontchaillou Hospital, Rennes, France.
Christophe
C
Leclercq
Federation of Cardiology, University Hospital Rangueil, Toulouse cedex 09, France.
Pierre
P
Mondoly
Hôpital Cardiologique du Haut-Lévêque, CHU Bordeaux, Université Bordeaux, IHU LIRYC, Bordeaux, France.
Pierre
P
Bordachar
D000328:Adult; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000628:therapy*; D002037:Bundle-Branch Block / Q000628:therapy; D058406:Cardiac Resynchronization Therapy; D002985:Clinical Protocols; D017147:Defibrillators, Implantable; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial; D018579:Patient Selection; D011446:Prospective Studies; D012107:Research Design; D013318:Stroke Volume; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000628:therapy*
Cardiac Resynchronization Therapy; QRS morphology; bundle branch block; efficacy