NCT02139891

Brief Summary

This study will examine the additional clinical benefit conferred by multipoint pacing (MPP) compared to standard CRT over a period of 3 months. Patients will be randomized to MPP ON vs. OFF and followed for a total of 6 months. This includes two crossover periods for each pacing modality (MPP on vs. off).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started May 2014

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

2 active sites

Status
completed

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

May 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

2.8 years

First QC Date

May 12, 2014

Last Update Submit

September 25, 2017

Conditions

Heart Failure

Keywords

Cardiac Resynchronization Therapynon respondersMultiPoint Pacing (MPP)

Outcome Measures

Primary Outcomes (1)

  • Changes in blood concentrations of N-terminal pro-B type natriuretic peptide (NT pro-BNP)

    Changes in plasma NT pro-BNP using the difference from baseline to three months as compared to the difference from three to six months within a patient.

    Baseline. 3-Month. 6-Month.

Secondary Outcomes (11)

  • Changes in Neurohormonal Activation

    Baseline. 3-Month. 6-Month.

  • Heart Failure Hospitalizations

    3-Month. 6-Month.

  • New York Heart Association (NYHA) Class changes

    Baseline. 3-Month. 6-Month.

  • Changes in Quality of Life (QOL), as assessed by the Minnesota Living With Heart Failure Questionnaire

    Baseline. 3-Month. 6-Month.

  • Echocardiographic changes

    Baseline. 3-Month. 6-Month.

  • +6 more secondary outcomes

Study Arms (2)

MultiPoint Pacing "On"

EXPERIMENTAL

Patients will be randomized to the MPP-ON Arm vs MPP-OFF in in crossover fashion with 3 months in each period.

Device: Cardiac Resynchronization Therapy with MultiPoint Pacing

MultiPoint Pacing "Off"

ACTIVE COMPARATOR

Patients will be randomized to the MPP-OFF arm vs MPP-ON in crossover fashion with 3 months in each period.

Device: Cardiac Resynchronization Therapy with MultiPoint Pacing

Interventions

Cardiac Resynchronization Therapy with MultiPoint PacingDEVICE
MultiPoint Pacing "Off"MultiPoint Pacing "On"

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients implanted with a St. Jude Medical CRT-D system with MPP capability
  • Patients must be willing and able to sign an appropriate informed consent form and comply with study requirements
  • NT pro-BNP levels equal to or greater than 500 pg/ml.

You may not qualify if:

  • History of stroke, PCI, myocardial infarction or unstable angina pectoris within the last 3 months.
  • Atrial fibrillation with noncontrolled heart rate
  • Need for intravenous inotropic support for CHF
  • Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
  • Undergone a cardiac transplantation
  • Currently participating in any other clinical investigation
  • Life expectancy \< 12 months due to a disorder other than CHF
  • Inability to comply with the follow-up procedures
  • Patients who are or may potentially be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istituto Clinico St. Ambrogio

Milan, 20149, Italy

Location

Policlinico Tor Vergata

Rome, Italy

Location

Related Publications (2)

  • Pappone C, Calovic Z, Vicedomini G, Cuko A, McSpadden LC, Ryu K, Romano E, Saviano M, Baldi M, Pappone A, Ciaccio C, Giannelli L, Ionescu B, Petretta A, Vitale R, Fundaliotis A, Tavazzi L, Santinelli V. Multipoint left ventricular pacing improves acute hemodynamic response assessed with pressure-volume loops in cardiac resynchronization therapy patients. Heart Rhythm. 2014 Mar;11(3):394-401. doi: 10.1016/j.hrthm.2013.11.023. Epub 2013 Nov 28.

    PMID: 24291411BACKGROUND

  • Rinaldi CA, Leclercq C, Kranig W, Kacet S, Betts T, Bordachar P, Gutleben KJ, Shetty A, Donal E, Keel A, Ryu K, Farazi TG, Simon M, Naqvi TZ. Improvement in acute contractility and hemodynamics with multipoint pacing via a left ventricular quadripolar pacing lead. J Interv Card Electrophysiol. 2014 Jun;40(1):75-80. doi: 10.1007/s10840-014-9891-1. Epub 2014 Mar 14.

    PMID: 24626999BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Giovanni B Forleo, MD, PhD

    University of Rome Tor Vergata

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD.

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 15, 2014

Study Start

May 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

September 26, 2017

Record last verified: 2017-09

Locations

IT(2)