ClinicalTrials.gg
Status unknownNCT04716270AALARAUpdated Sep 6, 2022

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

An observational study in Tachycardia, Supraventricular, sponsored by Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre. Status unknown at 1 site in Bahrain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-06.

Sponsored by Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
700
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Tachycardia, Supraventricular

Keywords

  • Supraventricular tachycardia
  • Radiation exposure
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In context

Tachycardia, Supraventricular

73 studies on the registry are indexed under Tachycardia, Supraventricular; 22 are open to participants now.

This study's planned enrollment of 700 is above the median of 87 across 28 observational studies indexed under Tachycardia, Supraventricular.

Browse Tachycardia, Supraventricular studies →

Lead sponsor

This is the only study on the registry with Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Patient is pregnant.
  • to ionizing radiation exposure
  • Patient's is less than 1 year
  • Associated complex congenital heart disease
  • Cardiac implantable electric devices
  • Known pathological venous access to the heart
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No

Interventions

  • ProcedureElectrophysiology Study and Ablation

    Electrophysiology Study and Ablation of Supraventricular Arrhythmias

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: The day of performing the procedure

  2. Incidence of procedure related cardiac Adverse Events (Safety)

    Cardiac related serious adverse events frequency during and after ablation procedure of supraventricular arrhythmias

    Time frame: 6 months

Secondary outcomes

  1. Fluoroscopy time

    Fluoroscopy time during the procedure

    Time frame: The day of performing the procedure

07

Study locations

1 of 1 sites recruiting
  • Mohamed Bin Khalifa Cardiac Center
    Ar Rifā', Bahrain
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04716270
Lead sponsor
Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre
Responsible party
Sponsor
First posted
Jan 20, 2021
Start date
Jan 20, 2021
Primary completion
Sep 2022 (estimated)
Completion
Mar 2023 (estimated)
Last update
Sep 6, 2022

Study contacts

MOHAMMAD AMIN
Contact
drmohdamin@gmail.com
0097317767739
Mohammad Amin, MRCP(UK)FHRS
principal investigator · Mohamed Bin Khalifa Cardiac Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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