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Completed

NCT Number: NCT04578275

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

diagnostic strategy using ECGI

Other

Procedure: Drug treatment, CVE, Pulmonary vein ablation isolation according to treatment guidelines and investigators discretion.

ECGI: customized body surface mapping (57 electrodes) at the inclusion in the study, after treatment assignment and prior to AF ablation procedure.

Primary outcomes

  1. ECGI calculation of frecuency maps(Hz)

    Time frame: 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

  2. ECGI calculation of frecuency of rotor maps

    Time frame: 12 months post-first intervention

    number of rotors mesasured Atrial Fibrillation Guidelines in relation to the ECGI AF complexity score

  3. ECGI AF complexity score calculated from the results of 1 and 2 to evaluate AF freedom from atrial fibrilation

    Time frame: 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 outcomes

  1. Freedom from atrial fibrillation treated according to the ESC/AHA atrial fibrillation Guidelines evaluated in binary(0:AF Freedom;1:AF)

    Time frame: 12 months post-first intervention

  2. Freedom from atrial fibrillation in patients undergoing rhythm control drug treatment.

    Time frame: at 6 and 12 months

  3. Freedom from atrial fibrillation and other atrial arrhythmias in patients undergoing surgical AF ablation.

    Time frame: at 6 and 12 months

  4. ECGI calculations of Highest Dominant Frecuency(Hz)

    Time frame: during ablation procedure and 12 months after

  5. ECGI calculations of Lowest Dominant Frecuency(Hz)

    Time frame: during ablation procedure and 12 months after

  6. ECGI calculations of Rotor duration from rotor maps(ms)

    Time frame: during ablation procedure and 12 months after

  7. ECGI calculations of simultaneus number of rotors from rotor maps(ms)

    Time frame: during ablation procedure and 12 months after

  8. Ablation procedure duration

    Time frame: Duration of ablation procedure

  9. Electrophysiological characteristics of the Atrial fibrillation complexity

    Time frame: 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)

  10. Electroanatomic reconstruction and recordings of electrical activity

    Time frame: During ablation procedure

    a three-dimensional reconstruction of atrium and coronary sinus is obtained using high density catheters and an electroanatomic navigation system.

  11. Fluoroscopy time

    Time frame: During ablation procedure, in minutes

  12. Trained Neural Network based on ECGI signals

    Time frame: 6 and 12 month post-ablation outcome prediction

Sponsors and collaborators

Lead sponsor

Felipe Atienza

Other

Collaborators

  • Universitat Politècnica de València

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2020
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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