Non-invasive Characterization of the Mechanisms of Atrial Fibrillation Maintenance

Atrial Fibrillation Clinical Trial

— PERSONALIZE  

Official title:

PERSONALIZE-AF: Non-invasive Characterization of the Mechanisms of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497248
• Other study ID #: PERSONALIZE-AF
• Status: Completed
• Start date: February 2015
• Est. completion date: June 2019

Study information

• Verified date: December 2021
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Pulmonary vein ablation
Simultaneous biatrial endocardial electroanatomical mapping by high-density basket catheter (64 pin) and customized body surface mapping (57 electrodes) followed by circumferential pulmonary vein ablation.

Locations

Country	Name	City	State
Spain	Felipe Atienza Fernandez	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon	Instituto de Salud Carlos III, Universitat Politècnica de València

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Atienza F, Almendral J, Ormaetxe JM, Moya A, Martínez-Alday JD, Hernández-Madrid A, Castellanos E, Arribas F, Arias MÁ, Tercedor L, Peinado R, Arcocha MF, Ortiz M, Martínez-Alzamora N, Arenal A, Fernández-Avilés 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial fibrillation off antiarrhythmic medications in patients with either paroxysmal, persistent AF or valvular stenosis AF.		12 months post-first ablation procedure
Secondary	Freedom from atrial fibrillation on or off antiarrhythmic medication post-first ablation procedure and after redo procedures.		at 6 and 12 months
Secondary	Freedom from atrial fibrillation and other atrial arrhythmias post-first ablation procedure and after redo procedures.		at 6 and 12 months
Secondary	Incidence of peri-procedural complications		during ablation procedure and 12 months after
Secondary	Procedure duration		Duration of ablation procedure, and valvuloplasty if indicated, in minutes
Secondary	Body surface recording analysis by 120 disposable electrodes distributed over the patient's chest and connected to the polygraph.		During ablation procedure, and valvuloplasty if indicated
Secondary	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.		During ablation procedure, and valvuloplasty if indicated
Secondary	Atrial fibrosis determination using late gadolinium enhancement-MRI		At 6 and 12 months
Secondary	Fluoroscopy time		During ablation procedure, and valvuloplasty if indicated, in minutes