Wolff-Parkinson-White SyndromeNCT04106622
Accessory Pathway Antegrade Effective Refractory Period Among WPW Patients: the Risk in Relation to the Location
An observational study of Wolff-Parkinson-White Syndrome, run by Assiut University.
Trial summary
To correlate the antegrade effective refractory period of the accessory pathway with its anatomical location in the heart. To investigate whether the accessory pathway location can predict the high risk nature of the accessory pathway Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wolff-Parkinson-White Syndrome
- What is being tested?
- electrophysiological study
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 Mar 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Wolff Parkinson White patients
- Inclusion criteria: all patients with WPW admitted to Assuit university hospital and subjected to invasive EPS
- Exclusion criteria:
- heart failure
- cardiomyopathy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Accessory Pathway Antegrade Effective Refractory Period Among Wolff Parkinson White Patients: the Risk in Relation to the Location
To correlate the antegrade effective refractory period of the accessory pathway with its anatomical location in the heart.
To investigate whether the accessory pathway location can predict the high risk nature of the accessory pathway
Read the detailed description
The Wolf-Parkinson-White (WPW) syndrome is a clinical entity characterized by the presence of ≥1 accessory pathways between the atria and the ventricles pre-disposing patients to arrhythmias. Anterograde conduction through the accessory pathway leads to preexcitation of the ventricles and a delta wave in the ECG. The prevalence of preexcitation in the general population has been estimated to be 1 to 3 in 1000 individuals. Although most asymptomatic patients with pre-excitation have a good prognosis, there is also a lifetime risk of malignant arrhythmias and SCD, estimated to be 0.1 % per patient year.
- More worrisome is the fact that this event can be the first manifestation of the disease in up to 53 % of patients.
- Atrial fibrillation (AF) can be a life-threatening arrhythmia in the WPW syndrome if the AV AP has a short anterograde refractory period (RP), allowing too many atrial impulses to be conducted to the ventricle.
- This will result in very high ventricular rates with possible deterioration into ventricular fibrillation (VF) and sudden death.
- Parameters proved to indicate high risk AP include AP effective refractory period <240 ms, shortest preexcited RR interval <250 ms
- Certain Locations were thought to be associated with higher risk of the accessory pathway like Septal localization which was significantly more frequent in patients with VF when compared with individuals with no VF but the overall number of patients is limited . .
These debatable relations between AP location and its risk stratification was not extensively studied in larger scale studies….
- Conditions
- Wolff-Parkinson-White Syndrome
- Being tested
- electrophysiological study
- Keywords
- Wolff-Parkinson-White Syndrome
- 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.
electrophysiological studyProcedure or surgery
To assess whether the AP is of high risk or not, for all patients the AERP of the AP will be determined by one of the following ways:
The cycle length at which abrupt and complete loss of pre-excitation occurs during exercise test. If this didn't happen, the patient will be subjected to invasive electrophysiologic study..
The Antegrade refractory period of the AP is measured during EPS as the shortest cycle length with one-to-one conduction over the AP by incremental atrial stimulation after which the QRS becomes narrow or no conduction occurs due to block of the impulse in the AP.
The shortest pre-excited R-R interval during spontaneous or induced AF.
| Study group | Role | What they receive |
|---|---|---|
| Wolff Parkinson White patients | The investigators will decide the location of the AP by:
- Invasively: if the patient is subjected to (EPS)
• There are different locations of AP To assess whether the AP is of high risk or not, for all patients the Antegrade refractory period of the APAERP of the AP will be determined by one of the following ways: ( AERP) is measured during EPS as the shortest cycle length with one-to-one conduction over the AP by incremental atrial stimulation after which the QRS becomes narrow or no conduction occurs due to block of the impulse in the AP. The shortest pre-excited R-R interval (SPERRI) during spontaneous or induced AF.
The AERP and the risk category of the AP according to its value, will be recorded in relation to the site of the AP determined in every case and compared between different accessory Locations to see whether some of these positions are more liable to be of higher risk or there is no differerence between different positions. Receives: Procedure: electrophysiological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
the antegrade refractory period during invasive EPS done for the patients
the values will be correlated to the site of the AP diagnosed be EPS.. according to the previous studies and the current guidelines, if the refractory period is < 250 ms, this is considered a high risk AP
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
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 Assiut UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Khairy Ibrahim, Assiut University
- Investigators
- M K Ibrahim, Msc, Principal investigator, Assiut UniversityS S Atta, Professor, Study director, Assiut UniversityS M Taha, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106622
- Sponsor's protocol ID
- WPW syndrome
- Status last verified
- Jan 2020
- First submitted
- 25 Sep 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accessory Pathway Antegrade Effective Refractory Period Among Wolff Parkinson White Patients: the Risk in Relation to the Location
- ClinicalTrials.gov ID
- NCT04106622
- Acronym / sponsor ID
- WPW syndrome
- Conditions
- Wolff-Parkinson-White Syndrome
- Keywords
- Wolff-Parkinson-White Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 27 Sep 2019 (actual)
- 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.
To correlate the antegrade effective refractory period of the accessory pathway with its anatomical location in the heart.
To investigate whether the accessory pathway location can predict the high risk nature of the accessory pathway
Detailed description
The Wolf-Parkinson-White (WPW) syndrome is a clinical entity characterized by the presence of ≥1 accessory pathways between the atria and the ventricles pre-disposing patients to arrhythmias. Anterograde conduction through the accessory pathway leads to preexcitation of the ventricles and a delta wave in the ECG. The prevalence of preexcitation in the general population has been estimated to be 1 to 3 in 1000 individuals. Although most asymptomatic patients with pre-excitation have a good prognosis, there is also a lifetime risk of malignant arrhythmias and SCD, estimated to be 0.1 % per patient year.
- More worrisome is the fact that this event can be the first manifestation of the disease in up to 53 % of patients.
- Atrial fibrillation (AF) can be a life-threatening arrhythmia in the WPW syndrome if the AV AP has a short anterograde refractory period (RP), allowing too many atrial impulses to be conducted to the ventricle.
- This will result in very high ventricular rates with possible deterioration into ventricular fibrillation (VF) and sudden death.
- Parameters proved to indicate high risk AP include AP effective refractory period <240 ms, shortest preexcited RR interval <250 ms
- Certain Locations were thought to be associated with higher risk of the accessory pathway like Septal localization which was significantly more frequent in patients with VF when compared with individuals with no VF but the overall number of patients is limited . .
These debatable relations between AP location and its risk stratification was not extensively studied in larger scale studies….
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wolff Parkinson White patients | – | Procedure: electrophysiological studyThe investigators will decide the location of the AP by: - Invasively: if the patient is subjected to (EPS) • There are different locations of AP To assess whether the AP is of high risk or not, for all patients the Antegrade refractory period of the APAERP of the AP will be determined by one of the following ways: ( AERP) is measured during EPS as the shortest cycle length with one-to-one conduction over the AP by incremental atrial stimulation after which the QRS becomes narrow or no conduction occurs due to block of the impulse in the AP. The shortest pre-excited R-R interval (SPERRI) during spontaneous or induced AF. The AERP and the risk category of the AP according to its value, will be recorded in relation to the site of the AP determined in every case and compared between different accessory Locations to see whether some of these positions are more liable to be of higher risk or there is no differerence between different positions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Wolff Parkinson White patients
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 |
|---|---|---|
| electrophysiological studyTo assess whether the AP is of high risk or not, for all patients the AERP of the AP will be determined by one of the following ways: The cycle length at which abrupt and complete loss of pre-excitation occurs during exercise test. If this didn't happen, the patient will be subjected to invasive electrophysiologic study.. The Antegrade refractory period of the AP is measured during EPS as the shortest cycle length with one-to-one conduction over the AP by incremental atrial stimulation after which the QRS becomes narrow or no conduction occurs due to block of the impulse in the AP. The shortest pre-excited R-R interval during spontaneous or induced AF. | Procedure or surgery | Wolff Parkinson White patients |
Primary outcome
the antegrade refractory period during invasive EPS done for the patients
Time frame: 2 hours
the values will be correlated to the site of the AP diagnosed be EPS.. according to the previous studies and the current guidelines, if the refractory period is < 250 ms, this is considered a high risk AP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
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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.
M K Ibrahim, Msc principal investigator
Assiut University
S S Atta, Professor study director
Assiut University
S M Taha, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Wolff-Parkinson-White Syndrome, run by Assiut University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M K Ibrahim, Msc (1152453334 ext. +20, mohamed011354@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the antegrade refractory period during invasive EPS done for the patients (time frame: 2 hours). 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 30 Jan 2020.