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

NCT05964660 | Recruiting

• 1 other identifier: MATRIX-VT
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Arrythmia

Keywords

Ventricular arrhythmia; Ventricular tachycardia; Stereotactic arrhythmia radioablation; Artificial intelligence; Motion management; Motion integration

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

VT Patients

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Luebeck: lead
• Institute for Robotics and Cognitive Systems, University of Luebeck, Germany: collaborator

Study Sites (1)

Klinik für Rhythmologie

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med.univ.

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 28, 2023
• Study Start: August 14, 2023
• Primary Completion: October 1, 2024
• Study Completion: March 1, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)