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

September 2, 2022 updated by: Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bahrain
      • Ar Rifā', Bahrain
        • Recruiting
        • Mohamed Bin Khalifa Cardiac Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male or female patients ≥ 18 years of age, indicated for supraventricular arrhythmias ablation according to the current local applicable guidelines

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation exposure dose
Time Frame: The day of performing the procedure
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
Incidence of procedure related cardiac Adverse Events (Safety)
Time Frame: 6 months
Cardiac related serious adverse events frequency during and after ablation procedure of supraventricular arrhythmias
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluoroscopy time
Time Frame: The day of performing the procedure
Fluoroscopy time during the procedure
The day of performing the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre

Investigators

  • Principal Investigator: Mohammad Amin, MRCP(UK)FHRS, Mohamed Bin Khalifa Cardiac Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 16, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

September 6, 2022

Last Update Submitted That Met QC Criteria

September 2, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 1.0 of 2020-08-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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