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Completed

NCT Number: NCT04299360

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

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

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Key information

Conditions

Cardiac Resynchronization Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Policlinico Mater Domini, Catanzaro, CZ, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Resynchronization Therapy device programming

Device

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

Primary outcomes

  1. Acute improvement in cardiac function (1)

    Time frame: 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.

  2. Acute improvement in cardiac function (2)

    Time frame: 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 outcomes

  1. Delayed response (1)

    Time frame: 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

  2. Delayed response (2)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Other

Registry information

Acronym: COMPACT-MPP

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Mar 6, 2020
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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