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

NCT ID: NCT06602635

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2024-10-23

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

RVOT origin

Patients with right ventricular outflow tract (RVOT) arrhythmias origin

ECG and clinical score

Intervention Type: 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

Patients with left ventricular outflow tract (LVOT) arrhythmias origin

ECG and clinical score

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Puerta del Mar

OTHER

Sponsor Role: collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

Cisanello University Hospital (Pisa, Italy)

UNKNOWN

Sponsor Role: collaborator

Maria Cecilia Hospital

OTHER

Sponsor Role: collaborator

Centro Medico Teknon

OTHER

Sponsor Role: lead

Responsible Party

Antonio Berruezo, MD, PhD

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vrije Universiteit Brussel

Brussels, Belgium, Belgium

Site Status: RECRUITING

Maria Cecilia Hospital

Cotignola, Italy, Italy

Site Status: RECRUITING

Niguarda Ca Granda Hospital

Milan, Italy, Italy

Site Status: RECRUITING

Cisanello University Hospital (Pisa, Italy)

Pisa, Italy, Italy

Site Status: RECRUITING

Teknon Medical Center

Barcelona, Spain, Spain

Site Status: RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, Spain, Spain

Site Status: RECRUITING

Countries

Belgium; Italy; Spain

Central Contacts

Antonio Berruezo, MD, PhD

Role: CONTACT

antonio.berruezo@quironsalud.es

3384090290

Facility Contacts

Carlo De Asmundis, MD, PhD

Role: primary

carlo.deasmundis@uzbrussel.be

Saverio Iacopino, MD, PhD

Role: primary

iacopino@iol.it

Patrizio Mazzone, MD, PhD

Role: primary

patrizio.mazzone@ospedaleniguarda.it

Giulio Zucchelli, MD, PhD

Role: primary

g.zucchelli@ao-pisa.toscana.it

Antonio Berruezo, MD, PhD

Role: primary

antonio.berruezo@quironsalud.es

+34 3384090290

Juan Fernández-Armenta, MD, PhD

Role: primary

juanfdezarmenta@gmail.com

References

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.

Reference Type: BACKGROUND

PMID: 36017572 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31159581 (View on PubMed)

Other Identifiers

Hybrid-score OTVA

Identifier Type: -

Identifier Source: org_study_id