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Clinical Impact of Autonomic Modulation After Pulmonary Vein Isolation

NCT ID: NCT02733913

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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atrial fibrillation pulmonary vein isolation heart rate turbulence baroreflex sensitivity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinik für Kardiologie, Pneumologie und Angiologie

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Kardiologie, Pneumologie und Angiologie

Klinik für Kardiologie, Pneumologie und Angiologie

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hisaki Makimoto, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Locations

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Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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PVI

Identifier Type: -

Identifier Source: org_study_id