Ablation of Supraventricular Arrhythmias With As Low As Reasonably Achievable X-Ray Exposure

Tachycardia, Supraventricular Clinical Trial

— AALARA  

Official title:

Ablation of Supraventricular Arrhythmias With As Low As Reasonably Achievable X-Ray Exposure (AALARA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04716270
• Other study ID #: Version 1.0 of 2020-08-05
• Status: Recruiting
• Start date: January 20, 2021
• Est. completion date: March 2023

Study information

• Verified date: September 2022
• Source: Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre
• Contact: MOHAMMAD AMIN
• Phone: 0097317767739
• Email: drmohdamin[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational study is to demonstrate a clinically significant reduction of ionizing radiation exposure during transcatheter ablation of supraventricular tachycardias using the EnSite precision mapping system in a real-world clinical setting without compromising efficacy and safety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: March 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients = 18 years of age
• Patient indicated for supraventricular arrhythmias ablation according to the current guidelines
• Patient is willing to provide written informed consent.

Exclusion Criteria:

• Patient is pregnant.
• Contraindications to ionizing radiation exposure
• Patient's life expectancy is less than 1 year
• Associated complex congenital heart disease
• Cardiac implantable electric devices
• Known pathological venous access to the heart

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Supraventricular

Intervention

Procedure:
• Electrophysiology Study and Ablation
Electrophysiology Study and Ablation of Supraventricular Arrhythmias

Locations

Country	Name	City	State
Bahrain	Mohamed Bin Khalifa Cardiac Center	Ar Rifa'

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre

Country where clinical trial is conducted

Bahrain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation exposure dose	The dose of ionizing radiation exposure in patients undergoing Supraventricular Tachycardia catheter ablation utilizing a non-fluoroscopic EnSite Precision 3D mapping system	The day of performing the procedure
Primary	Incidence of procedure related cardiac Adverse Events (Safety)	Cardiac related serious adverse events frequency during and after ablation procedure of supraventricular arrhythmias	6 months
Secondary	Fluoroscopy time	Fluoroscopy time during the procedure	The day of performing the procedure