MPP Narrow QRS:Pilot Study on Multipoint Pacing in Patients With QRS Beetwen 100 and 130 Msec

MPP Narrow QRS:Pilot Study on Multipoint Pacing in Patients With Narrow QRS

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Device: MultiPoint Pacing ON; Device: Implantable cardioverter-defibrillator (ICD)

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maurizio Gasparini, MD; Email: maurizio.gasparini@humanitas.it

Study Locations

• Italy
  • Crema, Italy
    • Ospedale Maggiore di Crema
    • Contact: Maurizio Landolina, MD
  • Milan, Italy, 20162
    • A.O. Niguarda Ca' Granda
    • Contact: Maurizio Lunati, MD
  • Pavia, Italy, 27100
    • Fondazione Irccs Policlinico San Matteo
    • Contact: Roberto Rordorf, MD
  • Rovigo, Italy
    • Ospedale S.Maria della Misericordia
    • Contact: Francesco Zanon, MD
  • Rozzano, Italy
    • Humanitas Research Hospital
    • Contact: Maurizio Gasparini, MD
  • Udine, Italy
    • Ospedale Santa Maria della Misericordia
    • Contact: Alessandro Proclemer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MPP ON; Patients will be randomized to the MPP-ON Arm vs Standard ICD	Device: MultiPoint Pacing ON; MultiPoint Pacing ON
Active Comparator: Standard ICD; Patients will be randomized to the MPP-ON Arm vs Standard ICD	Device: Implantable cardioverter-defibrillator (ICD); Implantable cardioverter-defibrillator (ICD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 6 and 12 months	up to 12 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 24 months	24-Months
Percentage of responder patients in term of increase of EF > 5 points % at 12 months Follow-Up	12-Months
Percentage of responder patients in term of increase of EF > 5 points % at 24 months Follow-Up	24-Months
Percentage of responder patients in term of BNP < 400 pg/ml at 12 months	12 Months

Collaborators and Investigators

• Sponsor: Humanitas Hospital, Italy
• Investigators: Principal Investigator: Maurizio Gasparini, MD, Humanitas Research Hospital-Rozzano-Italy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: March 27, 2015
• First Posted (Estimate): March 30, 2015

Study Record Updates

• Last Update Posted (Estimate): February 19, 2016
• Last Update Submitted That Met QC Criteria: February 18, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 1.0