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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00873470
Other study ID # BRD 08/9-I
Secondary ID
Status Terminated
Phase N/A
First received March 31, 2009
Last updated February 7, 2013
Start date February 2009
Est. completion date December 2012

Study information

Verified date February 2013
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 13
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 64 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label


Intervention

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

Locations

Country Name City State
France Nantes UH Nantes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of effective anterograde refractory period of accessory duct and its evolution for a follow up superior to 10 years Day 0 No
Secondary Triggering a supra-ventricular tachycardia during the stimulation. Day 0 No
Secondary Presence of symptoms linked to WPW syndrome during the interval separating the 2 esophageal stimulation. Day 0 No
See also
  Status Clinical Trial Phase
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Recruiting NCT06349109 - Physical Activity in Children With Wolff-Parkinson-White Syndrome
Not yet recruiting NCT04106622 - Accessory Pathway Antegrade Effective Refractory Period Among WPW Patients: the Risk in Relation to the Location
Completed NCT03301935 - Risk Assessment in Patients With Symptomatic- and Asymptomatic Preexcitation
Terminated NCT03207373 - Stress ECG Test for the Evaluation of the Risk of Sudden Cardiac Death in a Paediatric Cohort With WPW Pattern N/A