Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology (NICE CRT)

Medical University Innsbruck

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: Device programming

Study type: Interventional

Funder types: Other

Identifiers

NCT04662970

Version 1.2, 09.07.2019

Details and patient eligibility

About

The principal aim is to analyze total left and right ventricular activation time in different CRT device programming algorithms (SyncAV) measured by non-invasive electrophysiology

Full description

Patient specific anatomic parameters taken from the cardiac magnetic resonance examination will be the base for a semiautomatic model incorporating the conductivity of the heart, the lungs, blood and the torso. For this reason, a software package (AMIRA Developer, TGS Template Graphics Software, France) has been adapted to calculate a quasi static approximation of Maxwell equations.

After fusion of the T1 CMR scan and the ECG electrodes a model-based bidomain FEM is used for a step-wise measurement of the local activation times (resting potential: 290 mV; plateau: 0 mV; acceleration time: 3 ms) both Ende- and epicardially.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients after successful implantation of a CRT-D or CRT-P device in whom a cardiac magnetic resonance examination is possible and the device is equipped with the SyncAV® programming software
• left bundle branch block before CRT implantation
• PQ interval ≤ 250 ms before implantation

Exclusion criteria

• high-grade AV block
• any contraindication concerning a safe CMR performance including claustrophobia
• terminal heart failure (NYHA IV) or cardiac decompensation
• life expectancy < 1 year
• women with child-bearing potential, pregnancy
• drug abusus

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Device programming

Experimental group

Description:

according to different settings from the SyncAV algorithm

Treatment:

Device: Device programming