NCT00873470

Brief Summary

The study consists of the realization of a new esophageal stimulation for patients already stimulated 10 years ago. The investigators would like to make a long term evaluation of the evolution of anterograde effective refractory period of accessory duct in the WPW syndrome. This study will be realized by esophageal stimulation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

3.8 years

First QC Date

March 31, 2009

Last Update Submit

February 7, 2013

Conditions

Wolff-Parkinson-White Syndrome

Outcome Measures

Primary Outcomes (1)

  • Measurement of effective anterograde refractory period of accessory duct and its evolution for a follow up superior to 10 years

    Day 0

Secondary Outcomes (2)

  • Triggering a supra-ventricular tachycardia during the stimulation.

    Day 0

  • Presence of symptoms linked to WPW syndrome during the interval separating the 2 esophageal stimulation.

    Day 0

Study Arms (1)

Stimulation

EXPERIMENTAL

All patients included have the stimulation

Procedure: esophagal stimulation

Interventions

esophagal stimulationPROCEDURE

ECG (rest) esophagal stimulation (rest and during effort)

Stimulation

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \< age \< 64 years
  • First esophagal stimulation with evaluation of effective anterograde refractory period \> 10 years
  • Informed consent signed
  • Diagnosis of Wolff-Parkinson-White syndrome
  • No procedure of ablation of accessory duct

You may not qualify if:

  • Ablation of accessory duct
  • Patient with contraindication to esophageal stimulation
  • Patient with contraindication to effort test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes UH

Nantes, 44093, France

Location

MeSH Terms

Conditions

Wolff-Parkinson-White Syndrome

Condition Hierarchy (Ancestors)

Pre-Excitation SyndromesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 1, 2009

Study Start

February 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

FR(1)