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

Sponsor
Monaldi Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02713308
Collaborator
(none)
248
Enrollment
2
Locations
51
Anticipated Duration (Months)
124
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Observational, retrospective and perspective study with acute and chronic endpoints

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    248 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of MultiPoint Pacing Technology in CRT Patients With Reduced RV-to-LV Delay
    Actual Study Start Date :
    Jan 1, 2017
    Anticipated Primary Completion Date :
    Sep 1, 2020
    Anticipated Study Completion Date :
    Apr 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

    1. Rate of CRT responder patients [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Monaldi Hospital Naples Italy 80100
    2 Università della Campania "Luigi Vanvitelli" Naples Italy 80100

    Sponsors and Collaborators

    • Monaldi Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Antonio D'Onofrio, MD, Monaldi Hospital
    ClinicalTrials.gov Identifier:
    NCT02713308
    Other Study ID Numbers:
    • MP001
    First Posted:
    Mar 18, 2016
    Last Update Posted:
    Mar 12, 2020
    Last Verified:
    Mar 1, 2020

    Study Results

    No Results Posted as of Mar 12, 2020