NCT02713308

Brief Summary

Observational, retrospective and perspective study with acute and chronic endpoints

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

3.7 years

First QC Date

March 15, 2016

Last Update Submit

March 11, 2020

Conditions

Cardiac Resynchronization Therapy

Outcome Measures

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

    6 Months

Study Arms (2)

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)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with standard indication to CRT-D system implantation

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Monaldi Hospital

Naples, 80100, Italy

RECRUITING

Università della Campania "Luigi Vanvitelli"

Naples, 80100, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32004245DERIVED

Study Officials

  • Antonio D'Onofrio, MD

    Monaldi Hospital

    STUDY CHAIR

Central Study Contacts

Antonio D'Onofrio, MD

CONTACT

donofrioant1@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 18, 2016

Study Start

January 1, 2017

Primary Completion

September 1, 2020

Study Completion

April 1, 2021

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

IT(2)