Clinical trial NCT02402816: MPP Narrow QRS:Pilot Study on Multipoint Pacing in Patients With QRS Beetwen 100 and 130 Msec
Official title: MPP Narrow QRS:Pilot Study on Multipoint Pacing in Patients With Narrow QRS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: Humanitas Hospital, Italy
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess the impact of the Multi Point Pacing (MPP) feature in the treatment of patients with QRS beetwen 100 and 130 msec in patients candidate to ICD implant.


Eligibility criteria: Inclusion Criteria:

* Patients with EF \< 35% on OPT at least 3 months and candidate to ICD
* QRS duration: 100-130 ms
* Patients willing and able to comply with study requirements
* Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form
* Successful quadripolar LV lead implant (only for Treatment Group)

Exclusion Criteria:

* Myocardial Infarction, unstable angina within 40 days prior the enrollment
* Patients with no left ventricular contractile reserve after low dose dobutamine stress echocardiography test
* Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
* Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
* Primary valvular disease
* Unable to comply with the follow up schedule
* Less than 18 years of age
* Pregnant or are planning to become pregnant during the duration of the investigation
* Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
* Undergone a cardiac transplantation
* Life expectancy \< 12 months
* Patients with permanent Atrial fibrillation
* Patients with Nyha 1

Primary outcomes:
measure: Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 6 and 12 months
timeFrame: up to 12 Months
Secondary outcomes:
measure: Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 24 months
timeFrame: 24-Months
measure: Percentage of responder patients in term of increase of EF > 5 points % at 12 months Follow-Up
timeFrame: 12-Months
measure: Percentage of responder patients in term of increase of EF > 5 points % at 24 months Follow-Up
timeFrame: 24-Months
measure: Percentage of responder patients in term of BNP < 400 pg/ml at 12 months
timeFrame: 12 Months
Other outcomes:
Locations:
city: Crema
country: Italy
facility: Ospedale Maggiore di Crema
city: Milan
country: Italy
facility: A.O. Niguarda Ca' Granda
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Rovigo
country: Italy
facility: Ospedale S.Maria della Misericordia
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
city: Udine
country: Italy
facility: Ospedale Santa Maria della Misericordia
Study officials:
affiliation: Humanitas Research Hospital-Rozzano-Italy
name: Maurizio Gasparini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gasparini M, Galimberti P, Bragato R, Ghio S, Raineri C, Landolina M, Chieffo E, Lunati M, Mulargia E, Proclemer A, Facchin D, Rordorf R, Vicentini A, Marcantoni L, Zanon F, Klersy C. Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial. Trials. 2016 Dec 3;17(1):572. doi: 10.1186/s13063-016-1698-1.