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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05964660
Other study ID # MATRIX-VT
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 2023
Est. completion date June 2024

Study information

Verified date July 2023
Source University of Luebeck
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Locations

Country Name City State
Germany Klinik für Rhythmologie Luebeck Schleswig-Holstein

Sponsors (2)

Lead Sponsor Collaborator
University of Luebeck Institute for Robotics and Cognitive Systems, University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 month after complete data collection
Primary 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 1 month after complete data collection
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