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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06602635
Enrollment
100
Registered
2024-09-19
Start date
2022-01-04
Completion date
2024-10-23
Last updated
2024-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Ablation, ECG, Ventricular Arrhythmias

Keywords

Ventricular extrasystole, Premature ventricular complex, ecg, outflow tract ventricular arrhythmias

Brief summary

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

Interventions

DIAGNOSTIC_TESTECG and clinical score

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.

Sponsors

Hospital Universitario Puerta del Mar
CollaboratorOTHER
Vrije Universiteit Brussel
CollaboratorOTHER
Cisanello University Hospital (Pisa, Italy)
CollaboratorUNKNOWN
Maria Cecilia Hospital
CollaboratorOTHER
Centro Medico Teknon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Hybrid score performanceAt the moment of interventional procedureThe 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

MeasureTime frameDescription
Safety1 month after the procedure dateThe safety outcome is the incidence of post-procedural major adverse events

Countries

Belgium, Italy, Spain

Contacts

Primary ContactAntonio Berruezo, MD, PhD
antonio.berruezo@quironsalud.es3384090290

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026