Comparison of Multi-point Pacing and Conventional CRT Through Non-invasive Hemodynamics Measurement and Global Longitudinal Strain Assessment

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro52 enrolled

Overview

Pilot, perspective, multi-center non-randomized study comparing Multi-point pacing and conventional CRT through non-invasive hemodynamics measurement and Global Longitudinal Strain assessment

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cardiac Resynchronization Therapy

Interventions

Cardiac Resynchronization Therapy device programmingDEVICE

Implanted CRT-D devices settings will be programmed based on the best acute hemodynamic response assessed non-invasively

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Recent or scheduled implantation of CRT-D system with quadripolar lead and MPP technology in patient with indications to CRT according to current guidelines Exclusion Criteria: * Patients in Atrial Tachycardia (AT) or Atrial Fibrillation (AF) at the time of the enrollment or with persistent or long-standing persistent/chronic AF * NYHA IV patients * Right Bundle Branch Block

Locations (3)

Azienda Ospedaliera Policlinico Mater Domini

Catanzaro, CZ, Italy

AO Cardarelli

Naples, Italy

AOU Federico II

Naples, Italy

Outcomes

Primary Outcomes

Acute improvement in cardiac function (1)

change in dP/dtmax, expressed in mmHg/s, assessed through photoplethysmography. This assessment represents in a non-invasive fashion, the rise in pressure (P) developed inside left ventricle during contraction over time.

Time frame: 24-48 hours after CRT-D implantation

Acute improvement in cardiac function (2)

change in global longitudinal strain, assessed through echocardiography. This assessment elucidates longitudinal shortening of the left ventricle as a percentage (change in length as a proportion to baseline length). GLS is derived from speckle tracking, and analyzed by post-processing of apical images of the left ventricle.

Time frame: 24-48 hours after CRT-D implantation

Secondary Outcomes

Delayed response (1)

change in GLS. Participants will investigate whether left ventricular remodeling upon "patient-tailored" biventricular stimulation will behave differentially according to type of stimulation; the total amount of CRT-responder patients will be therefore considered

Time frame: 3 Months

Delayed response (2)

change in NYHA class. Participants will check if functional status will change after optimized biventricular stimulation therapy and will provide clinical data on CRT responders.

Time frame: 3 Months

Data from ClinicalTrials.gov

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