Clinical trial NCT06602635: Hybrid Score to Predict OTVA-SOO in Patients with Wide Basal QRS
Official title: A Hybrid Score to Predict the Origin of Outflow Tract Ventricular Arrhythmias in Patients with Intraventricular Conduction Disorders or Paced Rhythm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ECG
Ventricular Arrhythmias
Catheter Ablation
Keywords: Ventricular extrasystole
Premature ventricular complex
ecg
outflow tract ventricular arrhythmias
Lead sponsor: Centro Medico Teknon
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Puerta del Mar
name: Vrije Universiteit Brussel
name: Cisanello University Hospital (Pisa, Italy)
name: Maria Cecilia Hospital
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population undergoing catheter ablation for 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


Eligibility criteria: 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.

Primary outcomes:
measure: Hybrid score performance
timeFrame: At the moment of interventional procedure
Secondary outcomes:
measure: Safety
timeFrame: 1 month after the procedure date
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Vrije Universiteit Brussel
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
city: Milan
country: Italy
facility: Niguarda Ca Granda Hospital
city: Pisa
country: Italy
facility: Cisanello University Hospital (Pisa, Italy)
city: Barcelona
country: Spain
facility: Teknon Medical Center
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar
Study officials:
References:
citation: 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.
citation: 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.