ClinicalTrials.gg
Status unknownNCT02713308IMAGE-CRTUpdated Mar 12, 2020

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

An observational study in Cardiac Resynchronization Therapy, sponsored by Monaldi Hospital. Status unknown at 2 sites in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-03-12.

Sponsored by Monaldi Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
248
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Observational, retrospective and perspective study with acute and chronic endpoints

Read the 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

02

Conditions studied

  • Cardiac Resynchronization Therapy
03

In context

Lead sponsor

Monaldi Hospital is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with standard indication to CRT-D system implantation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Right Bundle Branch Block
  • Severe Irreversible Renal Failure (\<30)
  • IV
  • Atrio-Ventricular Block above the 1st grade
  • Prosthetic Valves
  • Atrial Fibrillation at implantation
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
248 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

06

What researchers measure

Primary outcomes

  1. Rate of CRT responder patients

    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

    Time frame: 6 Months

07

Study locations

2 of 2 sites recruiting
  • Monaldi Hospital
    Naples, 80100, Italy
    Recruiting
  • Università della Campania "Luigi Vanvitelli"
    Naples, 80100, Italy
    Recruiting
08

References and documents

Publications

  • Solimene F, Nigro G, Canciello M, Tavoletta V, Shopova G, Calvanese R, Rago A, La Rosa C, Nappi F, Viscusi M, Urraro F, Manzo G, Gallo P, Andriani A, Rovaris G, Palmisano P, Innocenti S, D'Onofrio A. Design and rationale of the Impact of MultiPoint pacing in CRT patients with reduced RV-to-LV delay (IMAGE-CRT) study. J Cardiovasc Med (Hagerstown). 2020 Mar;21(3):250-258. doi: 10.2459/JCM.0000000000000928. PubMed 32004245 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2017 (actual). Primary completion is estimated for Sep 2020, 44 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2016
First posted
Mar 18, 2016
StartActual
Jan 2017
Primary completionEst.
Sep 2020
CompletionEst.
Apr 2021
Last update
Mar 12, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02713308
Lead sponsor
Monaldi Hospital
Responsible party
Antonio D'Onofrio (MD, Monaldi Hospital) — Principal investigator
First posted
Mar 18, 2016
Start date
Jan 2017
Primary completion
Sep 2020 (estimated)
Completion
Apr 2021 (estimated)
Last update
Mar 12, 2020

Study contacts

Antonio D'Onofrio, MD
Contact
donofrioant1@gmail.com
Antonio D'Onofrio, MD
study chair · Monaldi Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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