Wolff-Parkinson-White Syndrome Anterograde Refractory Period of Accessory Duct - Tabular View

Tracking Information

First Received Date ^ICMJE

March 31, 2009

Last Updated Date

March 31, 2009

Start Date ^ICMJE

February 2009

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Measurement of effective anterograde refractory period of accessory duct and its evolution for a follow up superior to 10 years [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Triggering a supra-ventricular tachycardia during the stimulation. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
Presence of symptoms linked to WPW syndrome during the interval separating the 2 esophageal stimulation. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Wolff-Parkinson-White Syndrome Anterograde Refractory Period of Accessory Duct

Official Title ^ICMJE

Long Term Evolution of the Anterograde Refractory Period of Accessory Duct in the Wolff-Parkinson-White Syndrome

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Open Label, Uncontrolled, Single Group Assignment

Condition ^ICMJE

Wolff-Parkinson-White Syndrome

Intervention ^ICMJE

Procedure: esophagal stimulation

Study Arms / Comparison Groups

Experimental: All patients included have the stimulation

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2010

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

21 < 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

Exclusion Criteria:

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

Gender

Both

Ages

21 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Gilles Lande, MD

06 15 40 83 92

gilles.lande@chu-nantes.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00873470

Responsible Party

Anne Omnes, Nantes UH

Study ID Numbers ^ICMJE

BRD 08/9-I

Study Sponsor ^ICMJE

Nantes University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

Nantes University Hospital

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP