Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602635
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Hybrid Score to Predict OTVA-SOO in Patients with Wide Basal QRS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Hybrid Score to Predict the Origin of Outflow Tract Ventricular Arrhythmias in Patients with Intraventricular Conduction Disorders or Paced Rhythm
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mms 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
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 mms 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None