Atrial Fibrillation Stratification Based on the Arrhythmia Perpetuation Mechanisms

April 19, 2022 updated by: Felipe Atienza

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months post-first intervention
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
12 months post-first intervention
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
12 months post-first intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
Time Frame: 12 months post-first intervention
12 months post-first intervention
Freedom from atrial fibrillation in patients undergoing rhythm control drug treatment.
Time Frame: at 6 and 12 months
at 6 and 12 months
Freedom from atrial fibrillation and other atrial arrhythmias in patients undergoing surgical AF ablation.
Time Frame: at 6 and 12 months
at 6 and 12 months
ECGI calculations of Highest Dominant Frecuency(Hz)
Time Frame: during ablation procedure and 12 months after
during ablation procedure and 12 months after
ECGI calculations of Lowest Dominant Frecuency(Hz)
Time Frame: during ablation procedure and 12 months after
during ablation procedure and 12 months after
ECGI calculations of Rotor duration from rotor maps(ms)
Time Frame: during ablation procedure and 12 months after
during ablation procedure and 12 months after
ECGI calculations of simultaneus number of rotors from rotor maps(ms)
Time Frame: during ablation procedure and 12 months after
during ablation procedure and 12 months after
Ablation procedure duration
Time Frame: Duration of ablation procedure
Duration of ablation procedure
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)
Inclusion, rhythm vs rate treatment, ablation
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.
During ablation procedure
Fluoroscopy time
Time Frame: During ablation procedure, in minutes
During ablation procedure, in minutes
Trained Neural Network based on ECGI signals
Time Frame: 6 and 12 month post-ablation outcome prediction
6 and 12 month post-ablation outcome prediction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Felipe Atienza

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universitat Politècnica de València

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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