NCT02606071

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
436

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

3.1 years

First QC Date

November 6, 2015

Last Update Submit

September 25, 2017

Conditions

Keywords

cardiac resynchronization therapymultipoint left ventricular pacing

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction

    Changes in Left ventricular ejection fraction

    6 Months

Secondary Outcomes (4)

  • Heart Failure Hospitalizations

    12 months

  • Appropriate device interventions

    12 months

  • Echocardiographic changes

    12 months

  • QRS Duration

    Baseline and six months

Interventions

CRT-DDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \- Patients currently participating in any other clinical investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ospedale Santa Maria della Misericordia

Rovigo, Italy

Location

Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

Ospedale Maria Vittoria

Torino, Italy

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart FailureVentricular FibrillationTachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaCardiac Conduction System Disease

Study Officials

  • Giovanni Forleo

    Policlinico Tor Vergata

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 17, 2015

Study Start

August 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2018

Last Updated

September 26, 2017

Record last verified: 2017-09

Locations