Electrophysiological Effects of NACOS and AVK on Pulmonary Veins and Left Atrium in Paroxysmal AF Catheter Ablation

NCT02814955 | Unknown DMC

• 1 other identifier: A15-D20-VOL.25
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; pulmonary veins; oral anticoagulant; electrophysiology; anticoagulant drugs

Outcome Measures

Primary Outcomes (1)

• Reccurence of atrial fibrillation

  6 months

Secondary Outcomes (5)

• number of active pulmonary veins

  1 day

• Spontaneous cycle length in active pulmonary veins

  1 day

• Number of connected pulmonary veins

  1 day

• Measure of refractory period for each pulmonary veins and left atria

  1 day

• Number of re-connected pulmonary veins with ATP

  1 day

Study Arms (5)

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

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Alexandre Joachim

Caen, Basse Normandie, 14000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

cordarone

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Joachim Alexandre, MD

CONTACT

alexandre-j@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 28, 2016
• Study Start: June 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 28, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)