Left Atrial Volume as Predictor for Arrhythmic Events and CRT Response (iLAV)

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

Study Overview

• Status: Unknown
• Conditions: Left Atrial Volume

• Study Type: Observational
• Enrollment (Anticipated): 230

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy
    • Recruiting
    • Borgo Trento Hospital
    • Contact: Giovanni Morani; Phone Number: 045 812 1111; Email: giovanni.morani@ospedaleuniverona.it
  • Italy/Lecce
    • Tricase, Italy/Lecce, Italy
      • Recruiting
      • G. Panico Hospital
      • Contact: Pietro Palmisano; Email: clinical-rhythmdetect@isis.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical benefit	Left atrial volume/function in terms of clinical benefit; Clinical Composite Score evaluation; QoL evaluation	12 months
Cardiac remodelling	Left atrial volume/function in terms of cardiac remodelling; LVEF; LVESV/LVEF	6 months
Atrial arrhythmias	Left atrial volume/function role in terms of: atrial arrhythmias onset; Atrial arrhythmias burden	24 months
Ventricular arrhythmias	Left atrial volume/function in terms of: ventricular arrhythmias onset; ventricular arrhythmias burden	24 months

Collaborators and Investigators

• Sponsor: Ospedale Borgo Trento - Verona

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 20140002277

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No