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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04662970

Acronym

NICE CRT

Enrollment

Registered

2020-12-10

Start date

2020-01-01

Completion date

2027-12-31

Last updated

2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

DEVICEDevice programming

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Austria

Contacts

Primary ContactWolfgang Dichtl, MD PhD

dichtl@me.com004351250481388

Backup ContactFabian Barbieri, MD

fabian.barbieri@i-med.ac.at004351250482546

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026