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Effects of Multipoint Pacing CRT-D on Neurohormonal Activation.

NCT ID: NCT02139891

Last Updated: 2017-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-03-31

Brief Summary

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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).

Detailed Description

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Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders. Pacing activation from multiple separated left ventricular (LV) sites might improve the depolarization pattern, thereby promoting more physiological activation. To explore the effect of MPP on cardiac neuro-hormonal activity, the investigators will enroll approximately 30 patients who already underwent CRT-D implantation with a quadripolar LV lead connected to a device capable of MPP.

This pilot study will have a randomized, double-blind, cross-over design. Patients will be randomized to receive either standard biventricular pacing (MPP-OFF) or MPP (MPP-ON) within 4-6 months following the implantation procedure. Each subject will crossover to the other study group after three months. The baseline evaluation should be acquired prior to the device being programmed to the randomized setting. Repeat evaluations will be performed at the end of each 3 month crossover period.

Participation in this study will last approximately 6 months. Patients, as well as investigators other than the EP physicians, will be blinded to the pacing mode.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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MultiPoint Pacing "On"

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

Group Type EXPERIMENTAL

Cardiac Resynchronization Therapy with MultiPoint Pacing

Intervention Type DEVICE

MultiPoint Pacing "Off"

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

Group Type ACTIVE_COMPARATOR

Cardiac Resynchronization Therapy with MultiPoint Pacing

Intervention Type DEVICE

Interventions

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Cardiac Resynchronization Therapy with MultiPoint Pacing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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Giovanni B Forleo

MD, PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giovanni B Forleo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rome Tor Vergata

Locations

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Istituto Clinico St. Ambrogio

Milan, , Italy

Site Status

Policlinico Tor Vergata

Rome, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 24291411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24626999 (View on PubMed)

Other Identifiers

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PTVCARDIO022014

Identifier Type: -

Identifier Source: org_study_id