Left Atrial Volume as Predictor for Arrhythmic Events and CRT Response

Left Atrial Volume Clinical Trial

— iLAV  

Official title:

Left Atrial Volume as Predictor for Arrhythmic Events and CRT Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03141606
• Other study ID #: 20140002277
• Status: Recruiting
• Start date: April 2016
• Est. completion date: February 2020

Study information

• Verified date: July 2019
• Source: Ospedale Borgo Trento - Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: February 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Left Atrial Volume

Locations

Country	Name	City	State
Italy	G. Panico Hospital	Tricase	Italy/Lecce
Italy	Borgo Trento Hospital	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Borgo Trento - Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	CRT Predictor Index	Identification of left atrial index predicting CRT response	6 months
Secondary	Clinical benefit	Left atrial volume/function in terms of clinical benefit; Clinical Composite Score evaluation; QoL evaluation	12 months
Secondary	Cardiac remodelling	Left atrial volume/function in terms of cardiac remodelling; LVEF; LVESV/LVEF	6 months
Secondary	Atrial arrhythmias	Left atrial volume/function role in terms of: atrial arrhythmias onset; Atrial arrhythmias burden	24 months
Secondary	Ventricular arrhythmias	Left atrial volume/function in terms of: ventricular arrhythmias onset; ventricular arrhythmias burden	24 months