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RecruitingNCT05964660MATRIX-VTUpdated Aug 29, 2024

Echocardiography-based Motion Integration and Management for Substrate Characterization and STAR Therapy in Ventricular Tachycardias

An observational study in Ventricular Arrythmia, sponsored by University of Luebeck. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-29.

Sponsored by University of Luebeck · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Prospective, observational, single center, pilot study to analyze the feasibility of motion and structural data integration in patients with ventricular arrhythmia by means of artificial intelligence for improved arrhythmogenic substrate characterization and motion management during stereotactic arrhythmia radioablation.

Read the detailed description

This is a prospective, observational, single center, pilot study. Data from preprocedural contrast-enhanced cardiac computed tomography and optically-tracked 3D transthoracic echocardiography of patients receiving catheter ablation for ventricular arrhythmia will be analyzed by means of artificial intelligence in order to better characterize the ventricular arrhythmogenic substrate and to improve the definition methods of the planning target volume during the stereotactic arrhythmia radioablation therapy by integrating the motion data into volume demarcation.

02

Conditions studied

  • Ventricular Arrythmia

Keywords

  • Ventricular arrhythmia
  • Ventricular tachycardia
  • Stereotactic arrhythmia radioablation
  • Artificial intelligence
  • Motion management
  • Motion integration
03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's planned enrollment of 20 is below the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

University of Luebeck is the lead sponsor of 74 studies on the registry; 13 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

A total of 20 patients with indication for catheter ablation of ventricular arrhythmia (VA) (ventricular tachycardia (VT), ventricular fibrillation (VF), premature ventricular contraction (PVC)) and for preprocedural contract-enhanced cardiac computed tomography (CT) for cardiac structure characterization will be prospectively enrolled in the study. The therapeutic approach follows the current clinical standard.

Inclusion criteria

  • Age ≥ 18 years
  • Indication for catheter ablation of ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia, premature ventricular contractions)
  • Indication for preprocedural contrast-enhanced cardiac computed tomography for cardiac structure characterization

Exclusion criteria

Exclusion Criteria:

  • Platelet count \< 100,000 cells/mm3
  • BMI > 45 kg/m2 or \< 18 kg/m2
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • VT Patients

    Patients with indication for catheter ablation of ventricular arrhythmia and preprocedural contrast-enhanced cardiac computed tomography for cardiac structure characterization.

06

What researchers measure

Primary outcomes

  1. Feasibility of algorithm training to achieve improved arrhythmogenic substrate characterization

    The feasibility of training the artificial intelligence-based algorithm using the preprocedural contrast-enhanced cardiac computed tomography and optically-tracked 3D transthoracic echocardiography data to better define the ventricular arrhythmogenic substrate in patients exhibiting ventricular arrhythmias.

    Time frame: 1 month after complete data collection

  2. Feasibility of algorithm training to improve the planning target volume definition for stereotactic arrhythmia radioablation therapy

    The feasibility of training the artificial intelligence-based algorithm using the preprocedural contrast-enhanced cardiac computed tomography and optically-tracked 3D transthoracic echocardiography data to better define the planning target volume for stereotactic arrhythmia radioablation therapy

    Time frame: 1 month after complete data collection

07

Study locations

1 of 1 sites recruiting
  • Klinik für Rhythmologie
    Luebeck, Schleswig-Holstein 23538, Germany
    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 Aug 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05964660
Lead sponsor
University of Luebeck
Collaborators
Institute for Robotics and Cognitive Systems, University of Luebeck, Germany
Responsible party
Prof. Roland Richard Tilz (Professor Dr. med.univ., University of Luebeck) — Principal investigator
First posted
Jul 28, 2023
Start date
Aug 14, 2023
Primary completion
Oct 2024 (estimated)
Completion
Mar 2025 (estimated)
Last update
Aug 29, 2024

Oversight

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

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