Echocardiography-based Motion Integration and Management for Substrate Characterization and STAR Therapy in Ventricular Tachycardias (MATRIX-VT)

July 27, 2023 updated by: Prof. Roland Richard Tilz, University of Luebeck

New 3D-echocardiography-based Motion Integration and mAnagement for subsTrate characteRisation and Stereotactic Arrhythmia radIoablation tX in Ventricular Tachycardias- the MATRIX-VT Study

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23538
        • Klinik für Rhythmologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of algorithm training to achieve improved arrhythmogenic substrate characterization
Time Frame: 1 month after complete data collection
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.
1 month after complete data collection
Feasibility of algorithm training to improve the planning target volume definition for stereotactic arrhythmia radioablation therapy
Time Frame: 1 month after complete data collection
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
1 month after complete data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Collaborators

Institute for Robotics and Cognitive Systems, University of Luebeck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

July 19, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MATRIX-VT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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