NCT04106622

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

September 25, 2019

Last Update Submit

January 28, 2020

Conditions

Keywords

Wolff-Parkinson-White Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

    2 hours

Study Arms (1)

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.

Procedure: electrophysiological study

Interventions

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.

Wolff Parkinson White patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Wolff Parkinson White patients

You may qualify if:

  • all patients with WPW admitted to Assuit university hospital and subjected to invasive EPS

You may not qualify if:

  • heart failure
  • cardiomyopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wolff-Parkinson-White Syndrome

Condition Hierarchy (Ancestors)

Pre-Excitation SyndromesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • M K Ibrahim, Msc

    Assiut University

    PRINCIPAL INVESTIGATOR
  • S S Atta, Professor

    Assiut University

    STUDY DIRECTOR
  • S M Taha, Lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 27, 2019

Study Start

March 1, 2020

Primary Completion

March 1, 2022

Study Completion

March 1, 2023

Last Updated

January 30, 2020

Record last verified: 2020-01