Clinical Impact of Autonomic Modulation After Pulmonary Vein Isolation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733913
• Other study ID #: PVI
• Status: Completed
• Phase: N/A
• First received: February 18, 2016
• Last updated: November 9, 2017
• Start date: August 2014
• Est. completion date: March 31, 2017

Study information

• Verified date: November 2017
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of AF	Time measured in days to recurrence of AF	12 months
Secondary	effect of PVI on cardiac autonomic system utilizing HRT measurement		12 months
Secondary	effect of PVI on cardiac autonomic system utilizing BRS measurement		12 months
Secondary	association between measured parameters (HRT, BRS) and the recurrence of AF		12 months