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Atrial Fibrillation Stratification Based on the Arrhythmia Perpetuation Mechanisms

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ClinicalTrials.gov Identifier: NCT04578275
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Universitat Politècnica de València
Information provided by (Responsible Party):
Felipe Atienza, Hospital General Universitario Gregorio Marañon

Study Description
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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.

Condition or disease Intervention/treatment
Atrial Fibrillation 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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: STRATIFY TRIAL: Atrial Fibrillation Stratification Based on the Arrhythmia Perpetuation Mechanisms.
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: diagnostic strategy using ECGI

    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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
AF patients manifesting atrial fibrillation at the AF clinic
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04578275


Contacts
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Contact: Felipe Atienza +34914265028 fatienzaf@secardiologia.es
Contact: sandra vazquez +34915868844 consultadeinvestigacioncardio@iisgm.com

Locations
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Spain
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Felipe Atienza, MD PhD    +34914265028    fatienzaf@secardiologia.es   
Principal Investigator: Felipe Atienza, MD PhD         
Sub-Investigator: Ana Sanchez de la Nava, MS         
Sponsors and Collaborators
Felipe Atienza
Universitat Politècnica de València
More Information
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Responsible Party: Felipe Atienza, Head of cardiovascualar research and training, Cardiology Department, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT04578275    
Other Study ID Numbers: STRATIFY-AF
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes