Clinical trial NCT05964660: Echocardiography-based Motion Integration and Management for Substrate Characterization and STAR Therapy in Ventricular Tachycardias
Official title: New 3D-echocardiography-based Motion Integration and mAnagement for subsTrate characteRisation and Stereotactic Arrhythmia radIoablation tX in Ventricular Tachycardias- the MATRIX-VT Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventricular Arrythmia
Keywords: Ventricular arrhythmia
Ventricular tachycardia
Stereotactic arrhythmia radioablation
Artificial intelligence
Motion management
Motion integration
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: Institute for Robotics and Cognitive Systems, University of Luebeck, Germany
First posted: 2023-07-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of algorithm training to achieve improved arrhythmogenic substrate characterization
timeFrame: 1 month after complete data collection
measure: Feasibility of algorithm training to improve the planning target volume definition for stereotactic arrhythmia radioablation therapy
timeFrame: 1 month after complete data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Klinik für Rhythmologie
state: Schleswig-Holstein
Study officials:
References: