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

Recruiting

• Conditions: Ventricular Arrythmia

• Registration Number: NCT05964660
• Lead Sponsor: University of Luebeck

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.

Study Timeline

• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-07-27
• Study First Posted: 2023-07-28
• Study Start: 2023-08-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2024-10
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of algorithm training to improve the planning target volume definition for stereotactic arrhythmia radioablation therapy	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
Feasibility of algorithm training to achieve improved arrhythmogenic substrate characterization	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.

Trial Locations

Locations (1)

Klinik für Rhythmologie; 🇩🇪 Luebeck, Schleswig-Holstein, Germany