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

NCT04299360 | Completed

• 1 other identifier: 178
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 3

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

Conditions

Cardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24-48 hours after CRT-D implantation

Secondary Outcomes (2)

• Delayed response (1)

  3 Months

• Delayed response (2)

  3 Months

Study Arms (2)

standard BIV

the following group describes the effects of the left ventricular stimulation involving a dipole of two electrodes located inside a suitable vessel branch of the coronary sinus (CS). Standard BIV pacing modality can be achieved by either a quadripolar electrode implanted in the CS, of which only two poles will be used for cardiac resynchronization therapy, or by a bipolar electrode equipped with just two electrodes. The latter describes the old technology, requiring a change into typology of generator which has to display an IS-1 connection (due to different distal terminal of the electrode itself), instead of the new one IS-4 connection that has been developed for quadripolar electrodes.

MPP BIV

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.

Device: Cardiac Resynchronization Therapy device programming

Interventions

Cardiac Resynchronization Therapy device programming DEVICE

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

MPP BIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\- Patients with standard indications to CRT satisfying the study Inclusion and Exclusion Criteria

You may qualify if:

• Recent or scheduled implantation of CRT-D system with quadripolar lead and MPP technology in patient with indications to CRT according to current guidelines

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Mater Domini, Catanzaro: lead

Study Sites (3)

Azienda Ospedaliera Policlinico Mater Domini

Catanzaro, CZ, 88100, Italy

Location

AO Cardarelli

Napoli, 80100, Italy

Location

AOU Federico II

Napoli, 80100, Italy

Location

Related Publications (1)

• Passafaro F, Rapacciuolo A, Ruocco A, Ammirati G, Crispo S, Pasceri E, Santarpia G, Mauro C, Esposito G, Indolfi C, Curcio A. COMPArison of Multi-Point Pacing and ConvenTional Cardiac Resynchronization Therapy Through Noninvasive Hemodynamics Measurement: Short- and Long-Term Results of the COMPACT-MPP Study. Am J Cardiol. 2024 Mar 15;215:42-49. doi: 10.1016/j.amjcard.2023.12.057. Epub 2024 Jan 17.

  PMID: 38237796 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Cardiology

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: March 6, 2020
• Study Start: November 21, 2016
• Primary Completion: October 30, 2019
• Study Completion: February 27, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

IT (3)