Non-invasive Characterization of the Mechanisms of Atrial Fibrillation Maintenance

NCT02497248 | Completed DMC

• 1 other identifier: PERSONALIZE-AF
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Pulmonary Vein Ablation; Mitral stenosis; Body surface mapping

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Freedom from atrial fibrillation on or off antiarrhythmic medication post-first ablation procedure and after redo procedures.

  at 6 and 12 months

• Freedom from atrial fibrillation and other atrial arrhythmias post-first ablation procedure and after redo procedures.

  at 6 and 12 months

• Incidence of peri-procedural complications

  during ablation procedure and 12 months after

• Procedure duration

  Duration of ablation procedure, and valvuloplasty if indicated, in minutes

• 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

Study Arms (3)

- Patients with paroxysmal AF.

Patients with AF episodes that terminates spontaneously or with intervention in less than seven days with clinical indication of pulmonary vein ablation.

Procedure: Pulmonary vein ablation

- Patients with persistent AF.

Patients with AF episodes that fails to self-terminate within seven days or require pharmacologic or electrical cardioversion to restore sinus rhythm with clinical indication of pulmonary vein ablation..

Procedure: Pulmonary vein ablation

- Patients with mitral stenosis.

\- Patients with mitral stenosis and clinical indication for AF ablation undergoing percutaneous balloon mitral valvuloplasty (PBMV) with clinical indication of pulmonary vein ablation..

Procedure: Pulmonary vein ablation

Interventions

Pulmonary vein ablation PROCEDURE

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.

Also known as: Mitral Valvuloplasty in patients with severe mitral stenosis

- Patients with mitral stenosis.; - Patients with paroxysmal AF.; - Patients with persistent AF.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead
• Universitat Politècnica de València: collaborator
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Felipe Atienza Fernandez

Madrid, 28007, Spain

Location

Related Publications (1)

• 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.

  PMID: 25500229 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Mitral Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Felipe Atienza, MD

  Red de Investigación Cardiovascular

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 14, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

ES (1)