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RecruitingNCT04662970NICE CRTUpdated Oct 2, 2025

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

An interventional study of Device programming in Heart Failure, sponsored by Medical University Innsbruck. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.

Sponsored by Medical University Innsbruck · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2020, registered Nov 2020).
  • Started Jan 2020; still recruiting 6 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 25 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Medical University Innsbruck is the lead sponsor of 182 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Device programming

    according to different settings from the SyncAV algorithm

    Device: Device programming

Interventions

  • DeviceDevice programming

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

06

What researchers measure

Primary outcomes

  1. Optimal (shortest) activation time of the right and left ventricular in heart failure patients after CRT implantation

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

    Time frame: The measurements will be done at Day 1

07

Study locations

1 of 1 sites recruiting
  • Medical University Innsbruck
    Innsbruck, Tyrol 6020, Austria
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04662970
Lead sponsor
Medical University Innsbruck
Responsible party
Sponsor
First posted
Dec 10, 2020
Start date
Jan 1, 2020
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 2, 2025

Study contacts

Wolfgang Dichtl, MD PhD
Contact
dichtl@me.com
004351250481388
Fabian Barbieri, MD
Contact
fabian.barbieri@i-med.ac.at
004351250482546
Wolfgang Dichtl, MD PhD
principal investigator · Medical University Innsbruck

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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