title: Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial.
abstract: Despite an intensive search for predictors of the response to cardiac resynchronization therapy (CRT), the QRS duration remains the simplest and most robust predictor of a positive response. QRS duration of ≥ 130 ms is considered to be a prerequisite for CRT; however, some studies have shown that CRT may also be effective in heart failure (HF) patients with a narrow QRS (<130 ms). Since CRT can now be performed by pacing the left ventricle from multiple vectors via a single quadripolar lead, it is possible that multipoint pacing (MPP) might be effective in HF patients with a narrow QRS. This article reports the design of the MPP Narrow QRS trial, a prospective, randomized, multicenter, controlled feasibility study to investigate the efficacy of MPP using two LV pacing vectors in patients with a narrow QRS complex (100-130 ms).
  
  
  
  Fifty patients with a standard ICD indication will be enrolled and randomized (1:1) to either an MPP group or a Standard ICD group. All patients will undergo a low-dose dobutamine stress echo test and only those with contractile reserve will be included in the study and randomized. The primary endpoint will be the percentage of patients in each group that have reverse remodeling at 12 months, defined as a reduction in left ventricular end-systolic volume (LVESV) of >15% from the baseline.
  
  
  
  This feasibility study will determine whether MPP improves reverse remodeling, as compared with standard ICD, in HF patients who have a narrow QRS complex (100-130 ms).
  
  
  
  ClinicalTrials.gov, NCT02402816 . Registered on 25 March 2015.
authors.affiliation: Humanitas Research Hospital, Via Manzoni 56, Rozzano, Italy. maurizio.gasparini@humanitas.it.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Gasparini
authors.affiliation: Humanitas Research Hospital, Via Manzoni 56, Rozzano, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Galimberti
authors.affiliation: Humanitas Research Hospital, Via Manzoni 56, Rozzano, Italy.
authors.forename: Renato
authors.initials: R
authors.lastname: Bragato
authors.affiliation: Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Ghio
authors.affiliation: Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Raineri
authors.affiliation: Ospedale Maggiore, Crema, CR, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Landolina
authors.affiliation: Ospedale Maggiore, Crema, CR, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Chieffo
authors.affiliation: AO Niguarda Cà Granda, Milano, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Lunati
authors.affiliation: AO Niguarda Cà Granda, Milano, Italy.
authors.forename: Ederina
authors.initials: E
authors.lastname: Mulargia
authors.affiliation: Ospedale S. Maria della Misericordia, Udine, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Proclemer
authors.affiliation: Ospedale S. Maria della Misericordia, Udine, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Facchin
authors.affiliation: Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Rordorf
authors.affiliation: Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Vicentini
authors.affiliation: Ospedale Santa Maria della Misericordia, Rovigo, Italy.
authors.forename: Lina
authors.initials: L
authors.lastname: Marcantoni
authors.affiliation: Ospedale Santa Maria della Misericordia, Rovigo, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Zanon
authors.affiliation: Servizio di Biometria e Statistica, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
authors.forename: Catherine
authors.initials: C
authors.lastname: Klersy
mesh_terms: D002304:Cardiac Pacing, Artificial; D058406:Cardiac Resynchronization Therapy; D002985:Clinical Protocols; D017147:Defibrillators, Implantable; D004562:Electrocardiography; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy; D006801:Humans; D010865:Pilot Projects; D011446:Prospective Studies; D012107:Research Design
keywords: Cardiac resynchronization therapy; Heart failure; ICD; Multipoint pacing; Narrow QRS