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NCT Number: NCT04662970

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device programming

Device

Non-invasive electrophysiology with 65 ECG leads will be performed in 16 different device programming

Primary outcomes

  1. 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

    The activation time will be measured in 16 different device programming settings

Study contacts

Contact information is provided by the study sponsor or research team.

Fabian Barbieri, MD

CONTACT

[email protected]

004351250482546

Wolfgang Dichtl, MD PhD

CONTACT

[email protected]

004351250481388

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology: A Pilot Study

Acronym: NICE CRT

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Dec 10, 2020
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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