Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Device: Device programming

• Registration Number: NCT04662970
• Lead Sponsor: Medical University Innsbruck

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device programming	Device programming	according to different settings from the SyncAV algorithm

Primary Outcome Measures

Name	Time	Method
Optimal (shortest) activation time of the right and left ventricular in heart failure patients after CRT implantation	The measurements will be done at Day 1	The activation time will be measured in 16 different device programming settings

Trial Locations

Locations (1)

Medical University Innsbruck; 🇦🇹 Innsbruck, Tyrol, Austria