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

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 Overview

• Status: Completed
• Conditions: Cardiac Resynchronization Therapy
• Intervention / Treatment: Device: Cardiac Resynchronization Therapy device programming

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80100
    • AO Cardarelli
  • Napoli, Italy, 80100
    • AOU Federico II
  • CZ
    • Catanzaro, CZ, Italy, 88100
      • Azienda Ospedaliera Policlinico Mater Domini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Implanted CRT-D devices settings will be programmed based on the best acute hemodynamic response assessed non-invasively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	3 Months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2016
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): February 27, 2020

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 178

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No