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

Completed

• Conditions: Cardiac Resynchronization Therapy
• Interventions: Device: Cardiac Resynchronization Therapy device programming

• Registration Number: NCT04299360
• Lead Sponsor: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-21
• Study First Submitted: 2018-07-12
• Primary Completion: 2019-10-30
• Study Completion: 2020-02-27
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-06
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MPP BIV	Cardiac Resynchronization Therapy device programming	Such modality of left ventricular stimulation requires a dynamic use of the four electrodes located in the proximal segment of the electrocatheter that allows the recruitment of a vast area of the left ventricle. It is limited by the presence of scars on left ventricle surface, or phrenic nerve inadvertent stimulation.

Primary Outcome Measures

Name	Time	Method
Acute improvement in cardiac function (1)	24-48 hours after CRT-D implantation	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.
Acute improvement in cardiac function (2)	24-48 hours after CRT-D implantation	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.

Secondary Outcome Measures

Name	Time	Method
Delayed response (1)	3 Months	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
Delayed response (2)	3 Months	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.

Trial Locations

Locations (3)

AO Cardarelli; 🇮🇹 Napoli, Italy

AOU Federico II; 🇮🇹 Napoli, Italy

Azienda Ospedaliera Policlinico Mater Domini; 🇮🇹 Catanzaro, CZ, Italy