Electrophysiological Effects of NACOS and AVK on Pulmonary Veins and Left Atrium in Paroxysmal AF Catheter Ablation (NACO-VP)

Study of Electrophysiological Effects of NACOS and AVK on the Pulmonary Veins and the Left Atrium of Patients Referred for Paroxysmal AF Catheter Ablation

Atrial fibrillation (AF) is the most common cardiac arrhythmias with a constantly growing prevalence AF. The purpose of paroxysmal AF processing is to control outbreaks from these pulmonary veins, medicated way (antiarrhythmic) or interventional. Ablation (radiofrequency or cryotherapy) has become in this context recognized and effective treatment of AF. In addition, antithrombotic treatments in this context is a major treatments for the prevention of stroke (stroke). They are most often associated with antiarrhythmic treatment to prevent recurrence of AF or to slow it during a relapse.

Recent experimental studies have highlighted the direct electrophysiological properties of dabigatran and rivaroxaban in the pulmonary veins and the left atrium. Dabigatran demonstrated in this study that it induced a prolongation of potential action in the pulmonary veins and the left atrium and it decreased the incidence of FA-induced by stimulation. Conversely, rivaroxaban induces shortening of the action potential in the left atrium (untested properties in the pulmonary veins). To our knowledge, apixaban and warfarin have not been studied in this context.

It is therefore possible that some of the new oral anticoagulants (NACOS) or some AVK (fluindione and warfarin), have direct electrophysiological effects in the pulmonary veins and on the left atrium and could influence AF recurrences (with effect " antiarrhythmic-like "or rather a pro-arrhythmic effect) after ablation.A retrospective analysis conducted at the University Hospital of Caen on very low numbers suggest that patients on dabigatran would have less pulmonary veins connected in early ablation procedure that patients on warfarin or rivaroxaban. Despite the limitations inherent in this analysis (very low numbers, retrospective analysis, unique setting and having studied his own limits), these results are consistent with the fundamental studies, and thus encourage us to pursue our hypothesis to obtain more statistical power and reliability in our measurements and results.

We therefore propose the study of the electrophysiological effects of NACOS (apixaban, dabigatran, rivaroxaban) and warfarin (warfarin and fluindione) on the pulmonary veins and the left atrium of patients referred for ablation of paroxysmal AF (radiofrequency or cryotherapy ) the CHU of Caen and Tours and clinic Saint Martin Caen.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• France
  • Basse Normandie
    • Caen, Basse Normandie, France, 14000
      • Recruiting
      • Alexandre Joachim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population corresponds to all patients referred for paroxysmal atrial fibrillation radiofrequency ablation , clinically stable, at Caen University Hospital, Tours and Saint-Martin clinic.

These patients have a strict, rigorous and systematic follow after these ablation at 1, 3 and 6 months with routine ECG.

Description

Inclusion Criteria:

• All hospitalized patients for ablation of paroxysmal AF
• On healthy heart
• Sinus rhythm during the procedure
• Patient> 18 years

Exclusion Criteria:

• Patient <18 years
• Severe Mitral valve disease,
• underlying heart disease
• Patients refusing to participate to the study

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
referred for paroxysmal atrial fibrillation with fluindione
referred for paroxysmal atrial fibrillation with previscan
referred for paroxysmal atrial fibrillation with apixaban
referred for paroxysmal atrial fibrillation with rivaroxaban
referred for paroxysmal atrial fibrillation with dabigatran

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reccurence of atrial fibrillation	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of active pulmonary veins	Measure at the ostia with the lasso	1 day
Spontaneous cycle length in active pulmonary veins	Measure at the ostia with the lasso	1 day
Number of connected pulmonary veins	Measure at the ostia with the lasso	1 day
Measure of refractory period for each pulmonary veins and left atria	Measure at the ostia with the lasso for each VP, and with coronary sinus for the LA.	1 day
Number of re-connected pulmonary veins with ATP		1 day

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Estimate): June 28, 2016
• Last Update Submitted That Met QC Criteria: June 23, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: atrial fibrillation; electrophysiology; pulmonary veins; oral anticoagulant; anticoagulant drugs
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: A15-D20-VOL.25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES