Effects of Multipoint Pacing CRT-D on Neurohormonal Activation.

University of Rome Tor Vergata

Status

Completed

Conditions

Heart Failure

Treatments

Device: Cardiac Resynchronization Therapy with MultiPoint Pacing

Study type

Interventional

Funder types

Other

Identifiers

NCT02139891

PTVCARDIO022014

Details and patient eligibility

About

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).

Full description

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.

Enrollment

30 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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