Atrial Fibrillation Stratification Based on the Arrhythmia Perpetuation Mechanisms

NCT04578275 | Completed

• 1 other identifier: STRATIFY-AF
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

AF patients manifesting atrial fibrillation at the AF clinic

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Felipe Atienza: lead
• Universitat Politècnica de València: collaborator

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of cardiovascualar research and training, Cardiology Department

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: October 8, 2020
• Study Start: April 18, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)