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CompletedNCT02733913Updated Nov 14, 2017

Clinical Impact of Autonomic Modulation After Pulmonary Vein Isolation

An observational study in Atrial Fibrillation, sponsored by Klinik für Kardiologie, Pneumologie und Angiologie. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-14.

Sponsored by Klinik für Kardiologie, Pneumologie und Angiologie · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • atrial fibrillation
  • pulmonary vein isolation
  • heart rate turbulence
  • baroreflex sensitivity
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.

This study's enrollment of 50 is below the median of 300 across 1,362 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Klinik für Kardiologie, Pneumologie und Angiologie is the lead sponsor of 17 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who undergo PVI for paroxysmal AF

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • prior left atrial Ablation
  • left atrial diameter >55mm
  • frequent atrial extrasystole, frequent ventricular Extrasystole
  • Diabetes Mellitus
  • sleep apnea syndrome
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. recurrence of AF

    Time measured in days to recurrence of AF

    Time frame: 12 months

Secondary outcomes

  1. effect of PVI on cardiac autonomic system utilizing HRT measurement

    Time frame: 12 months

  2. effect of PVI on cardiac autonomic system utilizing BRS measurement

    Time frame: 12 months

  3. association between measured parameters (HRT, BRS) and the recurrence of AF

    Time frame: 12 months

07

Study locations

1 site
  • Division of Cardiology, Pulmonary Disease and Vascular Medicine
    Düsseldorf, 40225, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02733913
Lead sponsor
Klinik für Kardiologie, Pneumologie und Angiologie
Responsible party
Klinik für Kardiologie, Pneumologie und Angiologie (Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf) — Sponsor-investigator
First posted
Apr 12, 2016
Start date
Aug 2014
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017
Last update
Nov 14, 2017

Study contacts

Hisaki Makimoto, MD
principal investigator · Division of Cardiology, Pulmonary Disease and Vascular Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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