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/36017572Actively Recruiting
Led by Centro Medico Teknon · Updated on 2024-09-24
100
Participants Needed
6
Research Sites
3 weeks
Total Duration
C
Centro Medico Teknon
Lead Sponsor
H
Hospital Universitario Puerta del Mar
Collaborating Sponsor
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
Hybrid Score to Predict OTVA-SOO in Patients with Wide Basal QRS
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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)
Duration - 1 month after the procedure
Participants are monitored for safety following the interventional procedure.
1 follow-up visit (in-person)
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
A
Antonio Berruezo, MD, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Katja Zeppenfeld, Jacob Tfelt-Hansen, Marta de Riva...
https://pubmed.ncbi.nlm.nih.gov/36017572Robert D Anderson, Saurabh Kumar, Ramanathan Parameswaran...
https://pubmed.ncbi.nlm.nih.gov/31159581