Atrial Fibrillation
Conditions
Brief summary
This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology.
Detailed description
This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology, which has been introduced as a tool predicting ablation lesion depth. The index incorporates the following characteristics of radiofrequency point-by-point ablation: radiofrequency energy power, contact force, duration of ablation. Since the ablation index is calculated for every individual operator depending on his(her) personal skills, there is no a strict indication on the safe and effective range of the index. This registry aims to evaluate ablation index values used in different centers by different operators. Prospective information on arrhythmia recurrence rate and type, characteristics of redo ablations, characteristics of reconduction ablated areas will be gathered.
Interventions
PROCEDURECatheter ablation
Radiofrequency catheter pulmonary vein isolation
Sponsors
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* indications for catheter ablation of atrial fibrillation; * signed informed consent
Exclusion criteria
* Presence of contraindications to AF ablation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from atrial fibrillation | 1 year | Number of participants with no evidence of atrial tachyarrhythmia longer than 30 s in duration at 12 months after ablation, as detected by regular ECG monitoring according to centres' established practices (Holter monitoring every 3 months, implantable loop recorder, cardiac rhythm management device interrogation, other regular ECG screening). Data will be collected using a web-based system with electronic case report forms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute complications | 30 days | Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc) whithin 30 days after ablation. Data will be collected using a web-based system with electronic case report forms. |
| Procedure time | 180 minutes | Duration of the total ablation procedure and fluoroscopy needed to complete pulmonary vein isolation, expressed in minutes. |
| Fluoroscopy time | 24 hours | Fluoroscopy duration within the procedure |
| Electrical reconduction | 2 years | Number of participats with electrical reconduction into pulmonary veins as assessed during repeat procedures. |
Countries
Russia
Outcome results
None listed