Atrial Fibrillation Stratification Based on the Arrhythmia Perpetuation Mechanisms
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT04578275
- Lead Sponsor
- Felipe Atienza
- Brief Summary
Atrial fibrillation treatments have a limited efficacy and often cause long-term side effects. This study aims to develop and validate an ECGI system to risk stratification in patients with persistent AF, identifying the mechanisms responsible for the maintenance and the best treatment for ending it.
- Detailed Description
The MAIN GOAL of this project is to clinically validate the technology for the noninvasive identification of the mechanisms responsible for maintenance of AF using ECGI. To achieve this goal, the investigators will analyze the efficacy of different treatment options in persistent AF patients as a function of the results of the ECGI. Mainly, patients will be evaluated attending to the complexity of the patterns obtained. Moreover, the investigators will evaluate the treatment benefit of performing guided-ablation in conjunction with pulmonary vein isolation as compared to pulmonary vein isolation only. These analyses will be performed in patients with persistent AF arriving at the clinic to determine treatment options. AF outcomes following the treatment assigned therapy will be evaluated at 6 months and 1 year after.
These parameters are obtained from the ECGI map: histogram of rotors (number of rotors and location), Highest and Lowest Dominant Frequency (Hz), rotor duration (ms), simultaneous rotors (number of rotors) and signal entropy (normalized).
Wide antrum circumferential pulmonary vein isolation with demonstration of bidirectional block will be performed using standard cooled-tip radiofrequency catheters or cryoballoon catheters.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Patients with paroxysmal AF symptomatic and refractory to at least one antiarrhythmic medication arriving in atrial fibrillation to the AF clinic.
- Patients with paroxysmal AF undergoing AF ablation in whom AF was induced at the EP laboratory.
- Patients with persistent AF or long-term persistent AF attending the AF clinic.
- Patients must be able and willing to provide written informed consent to participate in the study.
- Prior anticoagulation for> 4 weeks or transesophageal echocardiogram excluding intracardiac thrombi.
Inclusion Criteria:
- Patients with paroxysmal AF symptomatic and refractory to at least one antiarrhythmic medication arriving in atrial fibrillation to the AF clinic.
- Patients with paroxysmal AF undergoing AF ablation in whom AF was induced at the EP laboratory.
- Patients with persistent AF or long-term persistent AF attending the AF clinic.
- Patients must be able and willing to provide written informed consent to participate in the study.
- Prior anticoagulation for> 4 weeks or transesophageal echocardiogram excluding intracardiac thrombi.
Exclusion Criteria:
- Patients with inadequate anticoagulation levels, left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on TEE prior to the procedure.
- Patients with moderate-to-severe mitral regurgitation.
- Patients with contraindications to systemic anticoagulation with heparin or coumadin.
- Patients who are or may potentially be pregnant.
- Current enrollment in another investigational drug or device study.
- Pacemaker or Implantable Cardioverter Defibrillator.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ECGI calculation of frecuency maps(Hz) 12 months post-first intervention Freedom from atrial fibrillation treated according to the ESC/AHA Atrial Fibrillation Guidelines in relation to the ECGI AF complexity score
ECGI calculation of frecuency of rotor maps 12 months post-first intervention number of rotors mesasured Atrial Fibrillation Guidelines in relation to the ECGI AF complexity score
ECGI AF complexity score calculated from the results of 1 and 2 to evaluate AF freedom from atrial fibrilation 12 months post-first intervention score calculated from the results of 1 and 2 to evaluate AF freedom from atrial fibrilation Atrial Fibrillation Guidelines in relation to the ECGI AF complexity score
- Secondary Outcome Measures
Name Time Method ECGI calculations of Highest Dominant Frecuency(Hz) during ablation procedure and 12 months after Ablation procedure duration Duration of ablation procedure Fluoroscopy time During ablation procedure, in minutes Freedom from atrial fibrillation and other atrial arrhythmias in patients undergoing surgical AF ablation. at 6 and 12 months ECGI calculations of Lowest Dominant Frecuency(Hz) during ablation procedure and 12 months after ECGI calculations of Rotor duration from rotor maps(ms) during ablation procedure and 12 months after ECGI calculations of simultaneus number of rotors from rotor maps(ms) during ablation procedure and 12 months after Freedom from atrial fibrillation treated according to the ESC/AHA atrial fibrillation Guidelines evaluated in binary(0:AF Freedom;1:AF) 12 months post-first intervention Freedom from atrial fibrillation in patients undergoing rhythm control drug treatment. at 6 and 12 months Electrophysiological characteristics of the Atrial fibrillation complexity Inclusion, rhythm vs rate treatment, ablation Atrial fibrillation characteristics will be assesed according to the parameters obtained from ECGi calculations. These parameters are obtained from the frecuency maps(Hz) and histogram of rotors(number of rotors and location) and include : Highest and Lowest Dominant Frecuency(Hz), rotor duration(ms) and simultaneous rotors(number of rotors)
Electroanatomic reconstruction and recordings of electrical activity During ablation procedure a three-dimensional reconstruction of atrium and coronary sinus is obtained using high density catheters and an electroanatomic navigation system.
Trained Neural Network based on ECGI signals 6 and 12 month post-ablation outcome prediction
Trial Locations
- Locations (1)
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain