Atrial Fibrillation Stratification Based on the Arrhythmia Perpetuation Mechanisms

STRATIFY TRIAL: Atrial Fibrillation Stratification Based on the Arrhythmia Perpetuation Mechanisms.

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: diagnostic strategy using ECGI

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

AF patients manifesting atrial fibrillation at the AF clinic

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECGI calculation of frecuency maps(Hz)	Freedom from atrial fibrillation treated according to the ESC/AHA Atrial Fibrillation Guidelines in relation to the ECGI AF complexity score	12 months post-first intervention
ECGI calculation of frecuency of rotor maps	number of rotors mesasured Atrial Fibrillation Guidelines in relation to the ECGI AF complexity score	12 months post-first intervention
ECGI AF complexity score calculated from the results of 1 and 2 to evaluate AF freedom from atrial fibrilation	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	12 months post-first intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Freedom from atrial fibrillation and other atrial arrhythmias in patients undergoing surgical AF ablation.		at 6 and 12 months
ECGI calculations of Highest Dominant Frecuency(Hz)		during ablation procedure and 12 months after
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
Ablation procedure duration		Duration of ablation procedure
Electrophysiological characteristics of the Atrial fibrillation complexity	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)	Inclusion, rhythm vs rate treatment, ablation
Electroanatomic reconstruction and recordings of electrical activity	a three-dimensional reconstruction of atrium and coronary sinus is obtained using high density catheters and an electroanatomic navigation system.	During ablation procedure
Fluoroscopy time		During ablation procedure, in minutes
Trained Neural Network based on ECGI signals		6 and 12 month post-ablation outcome prediction

Collaborators and Investigators

• Sponsor: Felipe Atienza
• Collaborators: Universitat Politècnica de València

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2018
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (ACTUAL): October 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: STRATIFY-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No