Wolff-Parkinson-White Syndrome Anterograde Refractory Per... | NCT00873470

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

NCT00873470

Sponsor

Nantes University Hospital

Status

Terminated

Last Update Posted

Feb 8, 2013Estimated

Enrollment

13Actual

Phase

Not Applicable

Conditions

Wolff-Parkinson-White Syndrome

Interventions

esophagal stimulation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Mar 31, 2009

First Submission Date that Met QC Criteria

Mar 31, 2009

First Posted Date

Apr 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2013

Last Update Posted Date

Feb 8, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stimulation	Experimental	All patients included have the stimulation	Procedure: esophagal stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
esophagal stimulation	Procedure	ECG (rest) esophagal stimulation (rest and during effort)	Stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of effective anterograde refractory period of accessory duct and its evolution for a follow up superior to 10 years		Day 0

Secondary Outcomes

Measure	Description	Time Frame
Triggering a supra-ventricular tachycardia during the stimulation.		Day 0
Presence of symptoms linked to WPW syndrome during the interval separating the 2 esophageal stimulation.		Day 0

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Nantes UH		Nantes		44093	France

Condition Browse Module

MeSH Terms

ID	Term
D014927	Wolff-Parkinson-White Syndrome

Ancestor Terms

ID	Term
D011226	Pre-Excitation Syndromes
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided