Clinical trial NCT02497248: Non-invasive Characterization of the Mechanisms of Atrial Fibrillation Maintenance
Official title: PERSONALIZE-AF: Non-invasive Characterization of the Mechanisms of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Pulmonary Vein Ablation
Mitral stenosis
Body surface mapping
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Universitat Politècnica de València
name: Instituto de Salud Carlos III
First posted: 2015-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AF patients with different mechanisms of maintenance (i.e. paroxysmal, persistent, valvular) and clinical indication for AF ablation.

Brief summary: Currently available antiarrhythmic drugs for the treatment of atrial fibrillation (AF) have a limited efficacy and often cause long-term side effects. Pulmonary vein isolation is the therapy of choice in drug-refractory patients. Recent studies have shown that ablation have a greater efficacy in patients in whom AF is maintained hierarchically and after ablation of rotors. The non-invasive identification of specific mechanism of AF maintenance in each patient could allow the selection of the most appropriate treatment.

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 by body surface electrical mapping. To achieve this goal, noninvasive mapping of the atrial activity will be correlated with simultaneous endocardial mapping (high density contact catheters) using advanced signal analyses techniques (Dominant frequency, phase and causality mapping, inverse solution problem). These analyses will be performed in patients with different mechanisms of maintenance of AF (e.g. paroxysmal, persistent, valvular) undergoing AF ablation for clinical indication. Both endocardial and body surface mapping results will be correlated with biomarkers levels, MRI scans and AF outcomes of AF ablation at 6 months and 1 year after the procedure.

Wide antrum circumferential pulmonary vein isolation with demonstration of bidirectional block will be performed using standard cooled-tip radiofrequency catheters. In patients with mitral stenosis, PBMV will be performed according to Inoue´s technique followed by wide antrum circumferential pulmonary vein isolation. In all patients, MRI/CT scans and fibrosis biomarkers will be obtained at baseline, 6 months and 1 year post ablation.

Eligibility criteria: Inclusion Criteria:

* Patients with paroxysmal AF symptomatic and refractory to at least one antiarrhythmic medication.
* Patients with persistent AF symptomatic and refractory to at least one antiarrhythmic medication.
* Patients with severe mitral stenosis (mitral valve area ≤1.5 cm2, stage D) and favorable valve morphology in the absence of left atrial thrombus or moderate-to-severe mitral regurgitation.
* 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 (in patients with paroxysmal AF).

Exclusion Criteria:

* Patients with inadequate anticoagulation levels.
* Patients with 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.
* Prior atrial fibrillation ablation.
* Patients who are or may potentially be pregnant.
* Contraindication for adenosine administration;
* Current enrollment in another investigational drug or device study.
* Pacemaker or Implantable Cardioverter Defibrillator.

Primary outcomes:
measure: Freedom from atrial fibrillation off antiarrhythmic medications in patients with either paroxysmal, persistent AF or valvular stenosis AF.
timeFrame: 12 months post-first ablation procedure
Secondary outcomes:
measure: Freedom from atrial fibrillation on or off antiarrhythmic medication post-first ablation procedure and after redo procedures.
timeFrame: at 6 and 12 months
measure: Freedom from atrial fibrillation and other atrial arrhythmias post-first ablation procedure and after redo procedures.
timeFrame: at 6 and 12 months
measure: Incidence of peri-procedural complications
timeFrame: during ablation procedure and 12 months after
measure: Procedure duration
timeFrame: Duration of ablation procedure, and valvuloplasty if indicated, in minutes
measure: Body surface recording analysis by 120 disposable electrodes distributed over the patient's chest and connected to the polygraph.
timeFrame: During ablation procedure, and valvuloplasty if indicated
measure: 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.
timeFrame: During ablation procedure, and valvuloplasty if indicated
measure: Atrial fibrosis determination using late gadolinium enhancement-MRI
timeFrame: At 6 and 12 months
measure: Fluoroscopy time
timeFrame: During ablation procedure, and valvuloplasty if indicated, in minutes
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Felipe Atienza Fernandez
Study officials:
affiliation: Red de Investigación Cardiovascular
name: Felipe Atienza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Atienza F, Almendral J, Ormaetxe JM, Moya A, Martinez-Alday JD, Hernandez-Madrid A, Castellanos E, Arribas F, Arias MA, Tercedor L, Peinado R, Arcocha MF, Ortiz M, Martinez-Alzamora N, Arenal A, Fernandez-Aviles F, Jalife J; RADAR-AF Investigators. Comparison of radiofrequency catheter ablation of drivers and circumferential pulmonary vein isolation in atrial fibrillation: a noninferiority randomized multicenter RADAR-AF trial. J Am Coll Cardiol. 2014 Dec 16;64(23):2455-67. doi: 10.1016/j.jacc.2014.09.053.