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NCT Number: NCT06602635

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

Outflow tract ventricular arrhythmia (OTVA) is the most common type of ventricular arrhythmia, and catheter ablation (CA) is the primary treatment option for patients experiencing symptoms. Accurately identifying the origin site of OTVA is essential for effective catheter ablation, minimizing procedural risks, and enhancing treatment success. However, most studies that developed algorithms or scoring systems for distinguishing OTVA origins excluded participants with structural heart disease and those with paced rhythms from their study groups. A recent prospective evaluation of a hybrid score (HS) that integrates both clinical and ECG data to predict OTVA-SOO, including patients with cardiac implantable electronic devices and those with structural heart disease in our study.

The presented study aimed to assess the effectiveness of the previously described hybrid algorithm in predicting OTVA-SOO in a patient population characterized by a wide basal QRS due to intraventricular conduction defects or paced rhythms.

The Hybrid Score The Hybrid Score (HS), involves a sum of points based on clinical and ECG characteristics. Points are assigned as follows: one point each for being over 50 years old, male, and having arterial hypertension. ECG-based points are allocated according to QRS transition: 3 points for a transition in V1, 2 points for V2, 1 point for V3 if the R-wave in V3 is greater than 1 mV; 1 point is subtracted if V3 has an R-wave less than 1 mV, and further deductions or additions apply for transitions up to V6. A score ≤ 1 suggests an RVOT origin, whereas ≥ 2 suggests an LVOT origin.

ECGs were recorded with a standard configuration at a 25 mm/s sweep speed.

Premature Ventricular Contraction (PVC) Ablation Activation mapping of spontaneous OTVAs was conducted. The procedure aimed to abolish spontaneous OTVAs, with the site of ablation marking the site of origin (SOO).

Collected data

* Patient Information and Consent (procedure must be done within 60 days of consent) * Demographics (age, gender, etc.) * Vital signs (length, weight, etc.) * Medical history, including cardiovascular risk factors, cardiomyopathy and drugs * ECG data * Echocardiographic data (left ventricular ejection fraction and left ventricular end-diastolic diameter) * Procedure data (number of radiofrequency applications, site of effective ablation, total radiofrequency time, total fluoro time, points mapping, procedure time) * Adverse Events

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vrije Universiteit Brussel, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ventricular arrhythmia with a morphology indicating an outflow tract origin and a wide basal QRS complex
  • a QRS width greater than 110 ms was considered wide
  • willing and capable of providing written informed consent to the study

Exclusion criteria

  • catether ablation procedure was unsuccessful
  • infrequent arrhythmia requiring ablation guided by pacemapping.

Treatment and study plan

ECG and clinical score

Diagnostic Test

The Hybrid Score (HS), detailed in previous literature involves a sum of points based on clinical and ECG characteristics. Points are assigned as follows: one point each for being over 50 years old, male, and having arterial hypertension. ECG-based points are allocated according to QRS transition: 3 points for a transition in V1, 2 points for V2, 1 point for V3 if the R-wave in V3 is greater than 1 mV; 1 point is subtracted if V3 has an R-wave less than 1 mV, and further deductions or additions apply for transitions up to V6. A score ≤ 1 suggests an RVOT origin, whereas ≥ 2 suggests an LVOT origin.

Primary outcomes

  1. Hybrid score performance

    Time frame: At the moment of interventional procedure

    The primary endpoint of the study is to establish the sensibility and specificity of an already validated clinical and electrocardiographic score for the prediction of left or right outflow tract ventricular arrhythmias in a selected population with large QRS because of intraventricular conduction disorders or paced rhythm who underwent catheter ablation of the arrhythmia.

Secondary outcomes

  1. Safety

    Time frame: 1 month after the procedure date

    The safety outcome is the incidence of post-procedural major adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Berruezo, MD, PhD

CONTACT

[email protected]

3384090290

Sponsors and collaborators

Lead sponsor

Centro Medico Teknon

Other

Collaborators

  • Cisanello University Hospital (Pisa, Italy)
  • Hospital Universitario Puerta del Mar
  • Maria Cecilia Hospital
  • Vrije Universiteit Brussel

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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