Wolff-Parkinson-White Syndrome Anterograde Refractory Period of Accessory Duct (WPW)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00873470
First received: March 31, 2009
Last updated: February 7, 2013
Last verified: February 2013
  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: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Long Term Evolution of the Anterograde Refractory Period of Accessory Duct in the Wolff-Parkinson-White Syndrome

Resource links provided by NLM:


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 ]

Enrollment: 13
Study Start Date: February 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stimulation
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Nantes UH
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00873470     History of Changes
Other Study ID Numbers: BRD 08/9-I
Study First Received: March 31, 2009
Last Updated: February 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Parkinson Disease
Wolff-Parkinson-White Syndrome
Pre-Excitation Syndromes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 22, 2014