Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial

Maurizio Gasparini, Paola Galimberti, Renato Bragato, Stefano Ghio, Claudia Raineri, Maurizio Landolina, Enrico Chieffo, Maurizio Lunati, Ederina Mulargia, Alessandro Proclemer, Domenico Facchin, Roberto Rordorf, Alessandro Vicentini, Lina Marcantoni, Francesco Zanon, Catherine Klersy, Maurizio Gasparini, Paola Galimberti, Renato Bragato, Stefano Ghio, Claudia Raineri, Maurizio Landolina, Enrico Chieffo, Maurizio Lunati, Ederina Mulargia, Alessandro Proclemer, Domenico Facchin, Roberto Rordorf, Alessandro Vicentini, Lina Marcantoni, Francesco Zanon, Catherine Klersy

Abstract

Background: 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).

Methods: 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.

Discussion: 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).

Trial registration: ClinicalTrials.gov, NCT02402816 . Registered on 25 March 2015.

Keywords: Cardiac resynchronization therapy; Heart failure; ICD; Multipoint pacing; Narrow QRS.

Figures

Fig. 1
Fig. 1
Study flow chart of the MPP Narrow QRS trial. Data will be collected from enrollment to 24-month follow-up

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