Italian Registry On Multipoint Left Ventricular Pacing

Heart Failure Clinical Trial

— IRON-MPP  

Official title:

Italian Registry On Multipoint Left Ventricular

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02606071
• Other study ID #: MPP04
• Status: Active, not recruiting
• Phase: N/A
• First received: November 6, 2015
• Last updated: September 25, 2017
• Start date: August 2013
• Est. completion date: September 2018

Study information

• Verified date: September 2017
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 436
• Est. completion date: September 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• CRT-D
HF patients treated in clinical practice with a CRT-D device

Locations

Country	Name	City	State
Italy	Ospedale Santa Maria della Misericordia	Rovigo
Italy	Casa Sollievo della Sofferenza	San Giovanni Rotondo
Italy	Ospedale Maria Vittoria	Torino

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction	Changes in Left ventricular ejection fraction	6 Months
Secondary	Heart Failure Hospitalizations		12 months
Secondary	Appropriate device interventions	Number of participants with appropriate device interventions (anti-tachycardia pacing or shock)	12 months
Secondary	Echocardiographic changes	Left ventricular end systolic volume	12 months
Secondary	QRS Duration	Changes in QSR duration between MPP and conventional biventricular pacing	Baseline and six months