Clinical trial NCT04578275: Atrial Fibrillation Stratification Based on the Arrhythmia Perpetuation Mechanisms
Official title: STRATIFY TRIAL: Atrial Fibrillation Stratification Based on the Arrhythmia Perpetuation Mechanisms.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Universitat Politècnica de València
First posted: 2020-10-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: AF patients manifesting atrial fibrillation at the AF clinic

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.

Eligibility criteria: 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:

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.

Primary outcomes:
measure: ECGI calculation of frecuency maps(Hz)
timeFrame: 12 months post-first intervention
measure: ECGI calculation of frecuency of rotor maps
timeFrame: 12 months post-first intervention
measure: ECGI AF complexity score calculated from the results of 1 and 2 to evaluate AF freedom from atrial fibrilation
timeFrame: 12 months post-first intervention
Secondary outcomes:
measure: Freedom from atrial fibrillation treated according to the ESC/AHA atrial fibrillation Guidelines evaluated in binary(0:AF Freedom;1:AF)
timeFrame: 12 months post-first intervention
measure: Freedom from atrial fibrillation in patients undergoing rhythm control drug treatment.
timeFrame: at 6 and 12 months
measure: Freedom from atrial fibrillation and other atrial arrhythmias in patients undergoing surgical AF ablation.
timeFrame: at 6 and 12 months
measure: ECGI calculations of Highest Dominant Frecuency(Hz)
timeFrame: during ablation procedure and 12 months after
measure: ECGI calculations of Lowest Dominant Frecuency(Hz)
timeFrame: during ablation procedure and 12 months after
measure: ECGI calculations of Rotor duration from rotor maps(ms)
timeFrame: during ablation procedure and 12 months after
measure: ECGI calculations of simultaneus number of rotors from rotor maps(ms)
timeFrame: during ablation procedure and 12 months after
measure: Ablation procedure duration
timeFrame: Duration of ablation procedure
measure: Electrophysiological characteristics of the Atrial fibrillation complexity
timeFrame: Inclusion, rhythm vs rate treatment, ablation
measure: Electroanatomic reconstruction and recordings of electrical activity
timeFrame: During ablation procedure
measure: Fluoroscopy time
timeFrame: During ablation procedure, in minutes
measure: Trained Neural Network based on ECGI signals
timeFrame: 6 and 12 month post-ablation outcome prediction
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
References: