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OpenTrials
Completed

NCT Number: NCT02733913

Clinical Impact of Autonomic Modulation After Pulmonary Vein Isolation

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. recurrence of AF

    Time frame: 12 months

    Time measured in days to recurrence of AF

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

Sponsors and collaborators

Lead sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 12, 2016
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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