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

September 21, 2024 updated by: Antonio Berruezo, MD, PhD, Centro Medico Teknon

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

General population undergoing catheter ablation for outflow tract ventricular arrhythmias

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RVOT origin
Patients with right ventricular outflow tract (RVOT) arrhythmias origin
Diagnostic test: ECG 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.
LVOT origin
Patients with left ventricular outflow tract (LVOT) arrhythmias origin
Diagnostic test: ECG 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the moment of interventional procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 1 month after the procedure date
The safety outcome is the incidence of post-procedural major adverse events
1 month after the procedure date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Medico Teknon

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2022

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

October 23, 2024

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 15, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 21, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hybrid-score OTVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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