Actively Recruiting

Age: 18Years +
All Genders
ID06602635

A Hybrid Score to Predict the Origin of Outflow Tract Ventricular Arrhythmias in Patients with Conduction Disorders or Paced Rhythm

Led by Centro Medico Teknon · Updated on 2024-09-24

100

Participants Needed

6

Research Sites

3 weeks

Total Duration

On this page

Sponsors

C

Centro Medico Teknon

Lead Sponsor

H

Hospital Universitario Puerta del Mar

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate a hybrid scoring system designed to predict the origin site of outflow tract ventricular arrhythmias (OTVA) in patients who have wide basal QRS complexes due to intraventricular conduction defects or paced rhythms. Accurately determining the origin of OTVA is important for guiding catheter ablation, which is the main treatment for symptomatic OTVA, helping to reduce risks and improve success. Previous studies excluded patients with structural heart disease or paced rhythms, but this study includes them to better assess the hybrid score's effectiveness. The study uses a hybrid score combining clinical data (age over 50, male sex, presence of arterial hypertension) and ECG features related to QRS transition points to distinguish between right ventricular outflow tract (RVOT) and left ventricular outflow tract (LVOT) origins. ECGs are recorded with standard settings, and activation mapping during spontaneous OTVA is performed to identify the ablation site. Patients are grouped based on whether their arrhythmia originates in the RVOT or LVOT. Participants provide consent and submit demographic, medical history, ECG, and echocardiographic data. The catheter ablation procedure is monitored collecting data on radiofrequency applications, procedure times, and mapping points. The main outcome measured is the hybrid score's predictive performance at the time of the procedure, with safety assessed one month afterward. Adverse events are tracked, and comprehensive clinical and procedural information is gathered to support the evaluation.

CONDITIONS

Brief Title

Hybrid Score to Predict OTVA-SOO in Patients with Wide Basal QRS

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ventricular arrhythmia with a morphology indicating an outflow tract origin and a wide basal QRS complex
  • A QRS width greater than 110 ms
  • Willing and capable of providing written informed consent to the study
Not Eligible

You will not qualify if you...

  • Catheter ablation procedure was unsuccessful
  • Infrequent arrhythmia requiring ablation guided by pacemapping only or not spontaneous arrhythmia suitable for mapping and ablation procedure
  • Conditions preventing successful ablation procedure or mapping of arrhythmia origin as per protocol requirements (implied by exclusion of unsuccessful procedures and pacemapping-only guidance)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - At the moment of interventional procedure

Participants undergo an ECG and clinical assessment to calculate the Hybrid Score, which helps predict the origin of ventricular arrhythmias.

1 visit (in-person)

Follow-up

Duration - 1 month after the procedure

Participants are monitored for safety following the interventional procedure.

1 follow-up visit (in-person)

Trial Site Locations

Total: 6 locations

1

Vrije Universiteit Brussel

Brussels, Belgium, Belgium, 1090

Actively Recruiting

2

Maria Cecilia Hospital

Cotignola, Italy, Italy, 48033

Actively Recruiting

3

Niguarda Ca Granda Hospital

Milan, Italy, Italy, 20132

Actively Recruiting

4

Cisanello University Hospital (Pisa, Italy)

Pisa, Italy, Italy, 56124

Actively Recruiting

5

Teknon Medical Center

Barcelona, Spain, Spain, 08022

Actively Recruiting

6

Hospital Universitario Puerta del Mar

Cadiz, Spain, Spain, 11009

Actively Recruiting

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Research Team

A

Antonio Berruezo, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death.

Katja Zeppenfeld, Jacob Tfelt-Hansen, Marta de Riva...

https://pubmed.ncbi.nlm.nih.gov/36017572

Differentiating Right- and Left-Sided Outflow Tract Ventricular Arrhythmias: Classical ECG Signatures and Prediction Algorithms.

Robert D Anderson, Saurabh Kumar, Ramanathan Parameswaran...

https://pubmed.ncbi.nlm.nih.gov/31159581