ECGNCT06602635
Hybrid Score to Predict OTVA-SOO in Patients with Wide Basal QRS
An observational study of ECG and Ventricular Arrhythmias, run by Centro Medico Teknon at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ECG, Ventricular Arrhythmias, Catheter Ablation
- What is being tested?
- ECG and clinical score
- How many people
- 100 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 4 Jan 2022to 23 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General population undergoing catheter ablation for outflow tract ventricular arrhythmias
Who may be able to join
- 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
Who cannot join
- catether ablation procedure was unsuccessful
- infrequent arrhythmia requiring ablation guided by pacemapping.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Italy3 sites, 3 recruiting
- Recruiting
Maria Cecilia Hospital
Cotignola, Italy, 48033
Saverio Iacopino, MD, PhD, iacopino@iol.it
- Recruiting
Niguarda Ca Granda Hospital
Milan, Italy, 20132
Patrizio Mazzone, MD, PhD, patrizio.mazzone@ospedaleniguarda.it
- Recruiting
Cisanello University Hospital (Pisa, Italy)
Pisa, Italy, 56124
Giulio Zucchelli, MD, PhD, g.zucchelli@ao-pisa.toscana.it
Spain2 sites, 2 recruiting
- Recruiting
Teknon Medical Center
Barcelona, Spain, 08022
Antonio Berruezo, MD, PhD, +34 3384090290, antonio.berruezo@quironsalud.es
- Recruiting
Hospital Universitario Puerta del Mar
Cadiz, Spain, 11009
Juan Fernández-Armenta, MD, PhD, juanfdezarmenta@gmail.com
Belgium1 site, 1 recruiting
- Recruiting
Vrije Universiteit Brussel
Brussels, Belgium, 1090
Carlo De Asmundis, MD, PhD, carlo.deasmundis@uzbrussel.be
About this study
Official title: 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.
Read more
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
- Being tested
- ECG and clinical score
- Keywords
- Ventricular extrasystole, Premature ventricular complex, ecg, outflow tract ventricular arrhythmias
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG and clinical scoreDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| RVOT origin | Patients with right ventricular outflow tract (RVOT) arrhythmias origin Receives: Diagnostic Test: ECG and clinical score | |
| LVOT origin | Patients with left ventricular outflow tract (LVOT) arrhythmias origin Receives: Diagnostic Test: ECG and clinical score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the moment of interventional procedure
Secondary outcomes (1)
Safety
The safety outcome is the incidence of post-procedural major adverse events
Measured: 1 month after the procedure date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Jan 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion23 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ECGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Medico Teknon
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Puerta del Mar, Vrije Universiteit Brussel, Cisanello University Hospital (Pisa, Italy), Maria Cecilia Hospital
- Responsible party
- Principal investigator, Antonio Berruezo, MD, PhD, Centro Medico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602635
- Sponsor's protocol ID
- Hybrid-score OTVA
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36017572Anderson 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.
PubMed 31159581
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Score to Predict the Origin of Outflow Tract Ventricular Arrhythmias in Patients with Intraventricular Conduction Disorders or Paced Rhythm
- ClinicalTrials.gov ID
- NCT06602635
- Acronym / sponsor ID
- Hybrid-score OTVA
- Conditions
- ECG, Ventricular Arrhythmias, Catheter Ablation
- Keywords
- Ventricular extrasystole, Premature ventricular complex, ecg, outflow tract ventricular arrhythmias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Medico TeknonUniversity, hospital or other
- Collaborators
- Hospital Universitario Puerta del Mar, Vrije Universiteit Brussel, Cisanello University Hospital (Pisa, Italy), Maria Cecilia Hospital
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 23 Oct 2024 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RVOT origin | – | Diagnostic Test: ECG and clinical scorePatients with right ventricular outflow tract (RVOT) arrhythmias origin |
| LVOT origin | – | Diagnostic Test: ECG and clinical scorePatients with left ventricular outflow tract (LVOT) arrhythmias origin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population undergoing catheter ablation for outflow tract ventricular arrhythmias
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- catether ablation procedure was unsuccessful
- infrequent arrhythmia requiring ablation guided by pacemapping.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG and clinical scoreThe 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. | Diagnostic test | LVOT origin, RVOT origin |
Primary outcome
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.
1 secondary outcome
Safety
Time frame: 1 month after the procedure date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Background: PubMed 36017572Zeppenfeld 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.
- Background: PubMed 31159581Anderson 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.
- Individual participant dataSharing planned: No
Related trials for ECG
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruitingPhase 4
Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures
Neonatal Seizure
RecruitingObservational study
Comprehensive Clinical Prediction Rule for Acute Heart Failure
Acute Heart Failure (AHF)
Recruiting
Systematic Ambulatory ECG Monitoring Following TAVI
Aortic Stenosis, Conduction Disturbances
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ECG and Ventricular Arrhythmias, run by Centro Medico Teknon at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Berruezo, MD, PhD (3384090290, antonio.berruezo@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hybrid score performance (time frame: At the moment of interventional procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06602635, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.