Effects of Multipoint Pacing CRT-D on Neurohormonal Activation.

University of Rome Tor Vergata30 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy with MultiPoint PacingDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

Istituto Clinico St. Ambrogio

Milan, Italy

Policlinico Tor Vergata

Rome, Italy

Outcomes

Primary Outcomes

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.