- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00873470
Wolff-Parkinson-White Syndrome Anterograde Refractory Period of Accessory Duct (WPW)
February 7, 2013 updated by: Nantes University Hospital
Long Term Evolution of the Anterograde Refractory Period of Accessory Duct in the Wolff-Parkinson-White Syndrome
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nantes, France, 44093
- Nantes Uh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stimulation
All patients included have the stimulation
|
ECG (rest) esophagal stimulation (rest and during effort)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Measurement of effective anterograde refractory period of accessory duct and its evolution for a follow up superior to 10 years
Time Frame: Day 0
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Triggering a supra-ventricular tachycardia during the stimulation.
Time Frame: Day 0
|
Day 0
|
|
Presence of symptoms linked to WPW syndrome during the interval separating the 2 esophageal stimulation.
Time Frame: Day 0
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
March 31, 2009
First Submitted That Met QC Criteria
March 31, 2009
First Posted (Estimate)
April 1, 2009
Study Record Updates
Last Update Posted (Estimate)
February 8, 2013
Last Update Submitted That Met QC Criteria
February 7, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Disease
- Congenital Abnormalities
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Pre-Excitation Syndromes
- Syndrome
- Parkinson Disease
- Wolff-Parkinson-White Syndrome
Other Study ID Numbers
- BRD 08/9-I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.