CClinicalTrials.gg
Status unknownNCT03226639VARIABLEUpdated Jul 24, 2017

Predictive Value of Aortic Stiffness on Recurrence of Atrial Fibrillation After Disconnection of Pulmonary Veins (VARIABLE).

An observational study in First Ablation of Atrial Fibrillation, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-24.

Sponsored by Hospices Civils de Lyon · Observational

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

The ablation of atrial fibrillation (FA) by disconnection of pulmonary veins is a burgeoning intervention. It allows a long-term treatment of this arrhythmia with a success rate of about 80%. There are, nevertheless, some recidivism.

Risk factors for recidivism are poorly codified and need further research. Indeed the identification of factors of poor prognosis could lead to not propose this procedure to the patients who present them and at least to inform them of an increased risk of failure.

To date, aortic stiffness has not been studied in the context of assessing the risk factors for FA recurrence after ablation. On a physiopathological level, the aortic stiffness leads to increase left ventricle's post-load. Cardiac remodeling was observed with diastolic dysfunction and increased left atrial size. That may constitute a substrate for FA recurrence.

In the literature, aortic stiffness can be measured in several ways:

  1. Measurement of systolo-diastolic variation of the inner diameter of the aorta by scanner or transesophageal Echography (ETO).
  2. Measuring of the Pulse Wave Velocity.
  3. Measurement of aortic calcifications.

The investigators propose to evaluate the impact of aortic stiffness on the recidivism of FA 6 months after ablation procedure performed in the Croix-Rousse cardiology's department.

02

Conditions studied

  • First Ablation of Atrial Fibrillation

Keywords

  • Atrial Fibrillation
  • First Ablation
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 100 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

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

04

Who can participate

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

Study population

Patient benefiting of a first Atrial Fibrillation's ablation by cryotherapy or radiofrequency within the Service of the Croix Rousse's hospital and having signed a consent for participate in this research.

Inclusion criteria

  • 18 years old of both sexes,
  • Patient carrying a paroxysmal or persistent atrial fibrillation, benefiting from a first procedure of atrial fibrillation's ablation in the in the Croix-Rousse cardiology's department.
  • Patient who signed the consent to participate in the study.

Exclusion criteria

Exclusion Criteria :

  • Patient carrying a permanent atrial fibrillation
  • Patient who're in atrial fibrillation during the ablation
  • Atrial fibrillation relapse's history after ablation
  • Pregnant and nursing women
  • Patients refusal.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Atrial fibrillation recurrences

    Atrial fibrillation recurrences after 6 months of ablation by Holter ECG

    Time frame: Month 6

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03226639
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jul 24, 2017
Start date
Nov 2016
Primary completion
May 2018 (estimated)
Completion
May 2018 (estimated)
Last update
Jul 24, 2017

Study contacts

Pierre LANTELME
Contact
pierre.lantelme@chu-lyon.fr
+33 4 72 07 16 67
Fatou LANGEVIN
Contact
fatou.langevin@chu-lyon.fr
+33 4 72 07 28 65
Pierre Lantelme
principal investigator · Hospices Civils de Lyon - Hôpital de la Croix rousse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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