NCT02402816

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.

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
50

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started May 2016

Geographic Reach
1 country

6 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

First Submitted

Initial submission to the registry

March 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

March 25, 2015

Last Update Submit

February 18, 2016

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 6 and 12 months

    up to 12 Months

Secondary Outcomes (4)

  • 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

Study Arms (2)

MPP ON

EXPERIMENTAL

Patients will be randomized to the MPP-ON Arm vs Standard ICD

Device: MultiPoint Pacing ON

Standard ICD

ACTIVE COMPARATOR

Patients will be randomized to the MPP-ON Arm vs Standard ICD

Device: Implantable cardioverter-defibrillator (ICD)

Interventions

MultiPoint Pacing ONDEVICE

MultiPoint Pacing ON

MPP ON
Implantable cardioverter-defibrillator (ICD)DEVICE

Implantable cardioverter-defibrillator (ICD)

Standard ICD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ospedale Maggiore di Crema

Crema, Italy

Location

A.O. Niguarda Ca' Granda

Milan, 20162, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Ospedale S.Maria della Misericordia

Rovigo, Italy

Location

Humanitas Research Hospital

Rozzano, Italy

Location

Ospedale Santa Maria della Misericordia

Udine, Italy

Location

Related Publications (1)

  • 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.

    PMID: 27927248DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • Maurizio Gasparini, MD

    Humanitas Research Hospital-Rozzano-Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurizio Gasparini, MD

CONTACT

maurizio.gasparini@humanitas.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 25, 2015

First Posted

March 30, 2015

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2018

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations

IT(6)