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

Cardiac Resynchronization Therapy Clinical Trial

— COMPACT-MPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04299360
• Other study ID #: 178
• Status: Completed
• Start date: November 21, 2016
• Est. completion date: February 27, 2020

Study information

• Verified date: March 2020
• Source: Azienda Ospedaliera Policlinico "Mater Domini"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 27, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy

Intervention

Device:
• Cardiac Resynchronization Therapy device programming
Implanted CRT-D devices settings will be programmed based on the best acute hemodynamic response assessed non-invasively

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Policlinico Mater Domini	Catanzaro	CZ
Italy	AO Cardarelli	Napoli
Italy	AOU Federico II	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Policlinico "Mater Domini"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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