Accessory Pathway Antegrade Effective Refractory Period Among WPW Patients: the Risk in Relation to the Location

Wolff-Parkinson-White Syndrome Clinical Trial

Official title:

Accessory Pathway Antegrade Effective Refractory Period Among Wolff Parkinson White Patients: the Risk in Relation to the Location

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04106622
• Other study ID #: WPW syndrome
• Status: Not yet recruiting
• Start date: March 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: January 2020
• Source: Assiut University
• Contact: M K Ibrahim, Msc
• Phone: 1152453334
• Email: mohamed011354[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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

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….

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

1. Inclusion criteria:

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

2. Exclusion criteria:

1. heart failure

2. cardiomyopathy

Related Conditions & MeSH terms

• Parkinson Disease
• Pre-Excitation Syndromes
• Wolff-Parkinson-White Syndrome

Intervention

Procedure:
• electrophysiological study
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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