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

Sponsor:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00873470

Purpose

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.

Condition	Intervention
Wolff-Parkinson-White Syndrome	Procedure: esophagal stimulation

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Single Group Assignment
Official Title:	Long Term Evolution of the Anterograde Refractory Period of Accessory Duct in the Wolff-Parkinson-White Syndrome

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial paroxysmal nonkinesigenic dyskinesia Parkinson disease short QT syndrome Wolff-Parkinson-White syndrome

MedlinePlus related topics: Esophagus Disorders Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	33
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stimulation: Experimental All patients included have the stimulation	Procedure: esophagal stimulation ECG (rest) esophagal stimulation (rest and during effort)

Eligibility

Ages Eligible for Study:	21 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873470

Contacts

Contact: Gilles Lande, MD

06 15 40 83 92

gilles.lande@chu-nantes.fr

Locations

France
Nantes UH	Recruiting
Nantes, France, 44093
Contact: Gilles Lande, MD 06 15 40 83 92 gilles.lande@chu-nantes.fr
Principal Investigator: Gilles Lande, MD

Sponsors and Collaborators

Nantes University Hospital

More Information

No publications provided

Responsible Party:	Nantes UH ( Anne Omnes )
Study ID Numbers:	BRD 08/9-I
Study First Received:	March 31, 2009
Last Updated:	March 31, 2009
ClinicalTrials.gov Identifier:	NCT00873470 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Wolff-Parkinson-White Syndrome
Heart Diseases
Disease
Cardiovascular Abnormalities
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Pathologic Processes

Parkinson Disease
Movement Disorders
Syndrome
Cardiovascular Diseases
Parkinsonian Disorders
Congenital Abnormalities
Heart Defects, Congenital
Arrhythmias, Cardiac
Pre-Excitation Syndromes

ClinicalTrials.gov processed this record on November 05, 2009