Wolff-Parkinson-White SyndromeWPWNCT00873470
Wolff-Parkinson-White Syndrome Anterograde Refractory Period of Accessory Duct
A study testing esophagal stimulation in people with Wolff-Parkinson-White Syndrome, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Wolff-Parkinson-White Syndrome
- What is being tested?
- esophagal stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Ablation of accessory duct
- Patient with contraindication to esophageal stimulation
- Patient with contraindication to effort test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Wolff-Parkinson-White Syndrome
- Being tested
- esophagal stimulation
- Medical subject headings
- Wolff-Parkinson-White Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophagal stimulationProcedure or surgery
ECG (rest) esophagal stimulation (rest and during effort)
| Study group | Role | What they receive |
|---|---|---|
| Stimulation | Experimental | All patients included have the stimulation Receives: Procedure: esophagal stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of effective anterograde refractory period of accessory duct and its evolution for a follow up superior to 10 years
Measured: Day 0
Secondary outcomes (2)
Triggering a supra-ventricular tachycardia during the stimulation.
Measured: Day 0
Presence of symptoms linked to WPW syndrome during the interval separating the 2 esophageal stimulation.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wolff-Parkinson-White SyndromeStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873470
- Sponsor's protocol ID
- BRD 08/9-I
- Acronym
- WPW
- Status last verified
- Feb 2013
- First submitted
- 31 Mar 2009
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Evolution of the Anterograde Refractory Period of Accessory Duct in the Wolff-Parkinson-White Syndrome
- ClinicalTrials.gov ID
- NCT00873470
- Acronym / sponsor ID
- WPW / BRD 08/9-I
- Conditions
- Wolff-Parkinson-White Syndrome
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stimulation | Experimental | Procedure: esophagal stimulationAll patients included have the stimulation |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Ablation of accessory duct
- Patient with contraindication to esophageal stimulation
- Patient with contraindication to effort test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esophagal stimulationECG (rest) esophagal stimulation (rest and during effort) | Procedure or surgery | Stimulation |
Primary outcome
Measurement of effective anterograde refractory period of accessory duct and its evolution for a follow up superior to 10 years
Time frame: Day 0
2 secondary outcomes
Triggering a supra-ventricular tachycardia during the stimulation.
Time frame: Day 0
Presence of symptoms linked to WPW syndrome during the interval separating the 2 esophageal stimulation.
Time frame: Day 0
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
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Comparative Outcomes of Radiofrequency Ablation of Concealed and Manifest Accessory Pathways: a Single Center, Retrospective Observational Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esophagal stimulation in people with Wolff-Parkinson-White Syndrome, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of effective anterograde refractory period of accessory duct and its evolution for a follow up superior to 10 years (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2013.