Italian Registry On Multipoint Left Ventricular Pacing (IRON-MPP)

Italian Registry On Multipoint Left Ventricular

The IRON-MPP is a prospective multicenter, observational registry designed to collect clinical and device data from a large cohort of HF patients treated in clinical practice with a CRT-D device with the ability to deliver Multi Point Pacing.

The purpose of the Registry is to collect data on how MPP-devices are being used by physicians in order to better understand how to improve the clinical care of patients and effectiveness of MPP therapy.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Ventricular Fibrillation; Ventricular Tachycardia
• Intervention / Treatment: Device: CRT-D

• Study Type: Observational
• Enrollment (Actual): 436

Contacts and Locations

Study Locations

• Italy
  • Rovigo, Italy
    • Ospedale Santa Maria della Misericordia
  • San Giovanni Rotondo, Italy
    • Casa Sollievo della Sofferenza
  • Torino, Italy
    • Ospedale Maria Vittoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HF patients treated in clinical practice with a CRT-D device with the ability to deliver MPP

Description

Inclusion Criteria:

- Patients implanted with a St. Jude Medical CRT-D system with MPP capability

Exclusion Criteria:

- Patients currently participating in any other clinical investigation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular ejection fraction	Changes in Left ventricular ejection fraction	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Failure Hospitalizations		12 months
Appropriate device interventions	Number of participants with appropriate device interventions (anti-tachycardia pacing or shock)	12 months
Echocardiographic changes	Left ventricular end systolic volume	12 months
QRS Duration	Changes in QSR duration between MPP and conventional biventricular pacing	Baseline and six months

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata
• Investigators: Principal Investigator: Giovanni Forleo, Policlinico Tor Vergata

Publications and helpful links

General Publications

• Forleo GB, Santini L, Giammaria M, Potenza D, Curnis A, Calabrese V, Ricciardi D, D'agostino C, Notarstefano P, Ribatti V, Morani G, Mantica M, Di Biase L, Bertaglia E, Calo L, Zanon F. Multipoint pacing via a quadripolar left-ventricular lead: preliminary results from the Italian registry on multipoint left-ventricular pacing in cardiac resynchronization therapy (IRON-MPP). Europace. 2017 Jul 1;19(7):1170-1177. doi: 10.1093/europace/euw094.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): September 1, 2016
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 16, 2015
• First Posted (Estimate): November 17, 2015

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 25, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: cardiac resynchronization therapy; multipoint left ventricular pacing
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: MPP04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No