Impact of MultiPoint Pacing Technology in CRT Patients With Reduced RV-to-LV Delay (IMAGE-CRT)

March 11, 2020 updated by: Antonio D'Onofrio, Monaldi Hospital
Observational, retrospective and perspective study with acute and chronic endpoints

Study Overview

Status

Unknown

Conditions

Detailed Description

Study to assess the benefit from Multipoint Pacing (MPP) in presence of RV-to-LV delay<80ms in terms of rate of CRT responder patients at 6 Months from CRT-D system implantation

Study Type

Observational

Enrollment (Anticipated)

248

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with standard indication to CRT-D system implantation

Description

Inclusion Criteria:

  • Indication to CRT-D system implantation according to current guidelines or CRT-D system already implanted in patient scheduled to CRT-D system implantation according to current guidelines

Exclusion Criteria:

  • Right Bundle Branch Block
  • Severe Irreversible Renal Failure (eGFR<30)
  • NYHA IV
  • Atrio-Ventricular Block above the 1st grade
  • Prosthetic Valves
  • Atrial Fibrillation at implantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group1-CRT
Patients with RV-to-LV delay≥80ms, CRT standard programming (single-point)
Group2-MPP
Patients with RV-to-LV delay<80ms, CRT programming with MPP (multi-point)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of CRT responder patients
Time Frame: 6 Months
A patient is considered "responder" if Left Ventricular End-Systolic Volume at 6 Months from CRT-D system implantation is reduced at least of 15% towards the baseline value
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monaldi Hospital

Investigators

  • Study Chair: Antonio D'Onofrio, MD, Monaldi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 18, 2016

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • MP001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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