Left Atrial Volume as Predictor for Arrhythmic Events and CRT Response

• Conditions: Left Atrial Volume

• Registration Number: NCT03141606
• Lead Sponsor: Ospedale Borgo Trento - Verona

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-05
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-01
• Primary Completion: 2019-11
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CRT Predictor Index	6 months	Identification of left atrial index predicting CRT response
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).

Secondary Outcome Measures

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

Trial Locations

Locations (2)

G. Panico Hospital; 🇮🇹 Tricase, Italy/Lecce, Italy

Borgo Trento Hospital; 🇮🇹 Verona, Italy