Clinical Impact of Autonomic Modulation After Pulmonary Vein Isolation

Clinical Impact of Autonomic Modulation After Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02733913

Enrollment

Registered

2016-04-12

Start date

2014-08-31

Completion date

2017-03-31

Last updated

2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, pulmonary vein isolation, heart rate turbulence, baroreflex sensitivity

Brief summary

Pulmonary vein isolation (PVI) has become a standard therapy for atrial fibrillation (AF), however, there is still considerable AF recurrence after PVI. Except for PV-left atrium (LA) reconnection, the cause of recurrence has been not yet fully clarified. The alternation of autonomic tone plays an important role in initiation of paroxysmal AF. It was reported that there are multiple gangliated plexus (GP) around pulmonary veins, therefore the modulation targeting those GPs, resulting in modulations of cardiac autonomic tone, have been conducted. Some study showed the efficacy of GP ablation for AF patients. According to the previous reports, heart rate (HR) increased, and heart rate variability (HRV) reduced after PVI. These are considered to be due to autonomic denervation caused by catheter ablation of GP. For the best of investigators knowledge, there have been no data on heart rate turbulence (HRT) of baroreflex sensitivity (BRS) concerning PVI.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients who undergo PVI for paroxysmal atrial fibrillation * Patients in sinus rhythm at baseline

Exclusion criteria

* prior left atrial Ablation * left atrial diameter \>55mm * frequent atrial extrasystole, frequent ventricular Extrasystole * Diabetes Mellitus * sleep apnea syndrome

Design outcomes

Primary

Measure	Time frame	Description
recurrence of AF	12 months	Time measured in days to recurrence of AF

Secondary

Measure	Time frame
effect of PVI on cardiac autonomic system utilizing HRT measurement	12 months
effect of PVI on cardiac autonomic system utilizing BRS measurement	12 months
association between measured parameters (HRT, BRS) and the recurrence of AF	12 months

Countries

Germany

Outcome results