Clinical Impact of Autonomic Modulation After Pulmonary Vein Isolation
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 18, 2016
CompletedFirst Posted
Study publicly available on registry
April 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedNovember 14, 2017
November 1, 2017
2.7 years
February 18, 2016
November 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recurrence of AF
Time measured in days to recurrence of AF
12 months
Secondary Outcomes (3)
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
Eligibility Criteria
Patients who undergo PVI for paroxysmal AF
You may qualify if:
- Patients who undergo PVI for paroxysmal atrial fibrillation
- Patients in sinus rhythm at baseline
You may not qualify if:
- prior left atrial Ablation
- left atrial diameter \>55mm
- frequent atrial extrasystole, frequent ventricular Extrasystole
- Diabetes Mellitus
- sleep apnea syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hisaki Makimoto, MD
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Klinik für Kardiologie, Pneumologie und Angiologie
Study Record Dates
First Submitted
February 18, 2016
First Posted
April 12, 2016
Study Start
August 1, 2014
Primary Completion
March 31, 2017
Study Completion
March 31, 2017
Last Updated
November 14, 2017
Record last verified: 2017-11