Left Atrial Volume as Predictor for Arrhythmic Events and CRT Response

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03141606

Acronym

iLAV

Enrollment

230

Registered

2017-05-05

Start date

2016-04-30

Completion date

2020-02-29

Last updated

2019-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Atrial Volume

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cardiac remodelling	6 months	Evaluation of function and volume of left atrium (by means of echocardiographic measures) in terms of cardiac remodelling (at least 15% reduction in LVESV).
CRT Predictor Index	6 months	Identification of left atrial index predicting CRT response

Secondary

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

Countries

Italy

Outcome results