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Atrial FibrillationNCT04578275

Atrial Fibrillation Stratification Based on the Arrhythmia Perpetuation Mechanisms

An observational study of Atrial Fibrillation, run by Felipe Atienza at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
diagnostic strategy using ECGI
How many people
200 participants
Where
1 siteSpain
Study dates
18 Apr 2018to 31 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: AF patients manifesting atrial fibrillation at the AF clinic

Who may be able to join

  • 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.
  • Patients with paroxysmal AF symptomatic and refractory to at least one antiarrhythmic medication arriving in atrial fibrillation to the AF clinic.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
diagnostic strategy using ECGI
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • diagnostic strategy using ECGIOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months post-first intervention

  2. ECGI calculation of frecuency of rotor maps

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

    Measured: 12 months post-first intervention

  3. 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

    Measured: 12 months post-first intervention

Secondary outcomes (12)

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

    Measured: 12 months post-first intervention

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

    Measured: at 6 and 12 months

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

    Measured: at 6 and 12 months

  4. ECGI calculations of Highest Dominant Frecuency(Hz)

    Measured: during ablation procedure and 12 months after

  5. ECGI calculations of Lowest Dominant Frecuency(Hz)

    Measured: during ablation procedure and 12 months after

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

    Measured: during ablation procedure and 12 months after

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

    Measured: during ablation procedure and 12 months after

  8. Ablation procedure duration

    Measured: Duration of ablation procedure

  9. 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)

    Measured: Inclusion, rhythm vs rate treatment, ablation

  10. 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.

    Measured: During ablation procedure

  11. Fluoroscopy time

    Measured: During ablation procedure, in minutes

  12. Trained Neural Network based on ECGI signals

    Measured: 6 and 12 month post-ablation outcome prediction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start18 Apr 2018
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04578275
Sponsor's protocol ID
STRATIFY-AF
Status last verified
Apr 2022
First submitted
5 Mar 2020
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Felipe Atienza at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ECGI calculation of frecuency maps(Hz) (time frame: 12 months post-first intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04578275.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.

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