NCT03141606

Brief Summary

Left atrial volume role for CRT response and for arrhythmic events (VT/VF/AT/AF) onset

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
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

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

Study Start

First participant enrolled

April 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

3.6 years

First QC Date

April 26, 2017

Last Update Submit

July 31, 2019

Conditions

Left Atrial Volume

Outcome Measures

Primary Outcomes (2)

  • Cardiac remodelling

    Evaluation of function and volume of left atrium (by means of echocardiographic measures) in terms of cardiac remodelling (at least 15% reduction in LVESV).

    6 months

  • CRT Predictor Index

    Identification of left atrial index predicting CRT response

    6 months

Secondary Outcomes (4)

  • Clinical benefit

    12 months

  • Cardiac remodelling

    6 months

  • Atrial arrhythmias

    24 months

  • Ventricular arrhythmias

    24 months

Eligibility Criteria

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

Patients implanted with cardiac resynchronization therapy defirbillator devices and who meet the inclusion and exclusion criteria

You may qualify if:

  • Patient with left ventricular ejection fraction ≤ 35%, II, III or IV NYHA Class, even if optimal medical therapy.
  • Patients with standard indication to CRT according current guideline, sinus rhythm at implantation, LBBB and QRS duration \>= 120 ms
  • Patients who will undergo to a new CRT-defibrillator system implantation
  • Patients who are able to understand and sign the informed consent
  • Patients who are able to attend all required follow-up visits at the study centerfor 24 months

You may not qualify if:

  • Age \< 18 years
  • Women who are pregnant or who are planning to become pregnant
  • Patients with permanent Atrial Fibrillation or persistent Atrial Fibrillation in the 90 days preceding the implantation
  • Patients with organic mitral valve disease
  • Patients with prosthetic heart valves
  • Patients who will undergo to upgrading from other devices (PM or ICD) to CRT, heart transplantation, patients with CRT devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

G. Panico Hospital

Tricase, Italy/Lecce, Italy

RECRUITING

Borgo Trento Hospital

Verona, Italy

RECRUITING

Study Design

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

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 5, 2017

Study Start

April 1, 2016

Primary Completion

November 1, 2019

Study Completion

February 1, 2020

Last Updated

August 1, 2019

Record last verified: 2019-07

Locations

IT(2)