Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Device programming.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology: A Pilot Study
Overview
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.
Interventions
- Device Device programming
Non-invasive electrophysiology with 65 ECG leads will be performed in 16 different device programming
Primary outcome measures
- Optimal (shortest) activation time of the right and left ventricular in heart failure patients after CRT implantation [Time frame: The measurements will be done at Day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Austria · 1 center
- Medical University Innsbruck — Innsbruck
Identifiers
NCT: NCT04662970 · Version 1.2, 09.07.2019