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

NCT06602635 | Recruiting DMC

• 1 other identifier: Hybrid-score OTVA
• Study Type: observational
• Target: 100
• Locations: 3 countries
• Sites: 6

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

Conditions

ECG; Ventricular Arrhythmias; Catheter Ablation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hybrid score performance

  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 Outcomes (1)

• Safety

  1 month after the procedure date

Study Arms (2)

RVOT origin

Patients with right ventricular outflow tract (RVOT) arrhythmias origin

Diagnostic Test: ECG and clinical score

LVOT origin

Patients with left ventricular outflow tract (LVOT) arrhythmias origin

Diagnostic Test: ECG and clinical score

Interventions

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.

LVOT origin; RVOT origin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population undergoing catheter ablation for outflow tract ventricular arrhythmias

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centro Medico Teknon: lead
• Hospital Universitario Puerta del Mar: collaborator
• Vrije Universiteit Brussel: collaborator
• Cisanello University Hospital (Pisa, Italy): collaborator
• Maria Cecilia Hospital: collaborator

Study Sites (6)

Vrije Universiteit Brussel

Brussels, Belgium, 1090, Belgium

RECRUITING

Maria Cecilia Hospital

Cotignola, Italy, 48033, Italy

RECRUITING

Niguarda Ca Granda Hospital

Milan, Italy, 20132, Italy

RECRUITING

Cisanello University Hospital (Pisa, Italy)

Pisa, Italy, 56124, Italy

RECRUITING

Teknon Medical Center

Barcelona, Spain, 08022, Spain

RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, Spain, 11009, Spain

RECRUITING

Related Publications (2)

• Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available.

  PMID: 36017572 BACKGROUND

• Anderson RD, Kumar S, Parameswaran R, Wong G, Voskoboinik A, Sugumar H, Watts T, Sparks PB, Morton JB, McLellan A, Kistler PM, Kalman J, Lee G. Differentiating Right- and Left-Sided Outflow Tract Ventricular Arrhythmias: Classical ECG Signatures and Prediction Algorithms. Circ Arrhythm Electrophysiol. 2019 Jun;12(6):e007392. doi: 10.1161/CIRCEP.119.007392. Epub 2019 Jun 4.

  PMID: 31159581 BACKGROUND

MeSH Terms

Conditions

Ventricular Premature Complexes

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Antonio Berruezo, MD, PhD

CONTACT

3384090290; antonio.berruezo@quironsalud.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: January 4, 2022
• Primary Completion: September 30, 2024
• Study Completion: October 23, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); BE (1); IT (3)