Tachycardia, SupraventricularAALARANCT04716270
Ablation of Supraventricular Arrhythmias With As Low As Reasonably Achievable X-Ray Exposure
An observational study of Tachycardia, Supraventricular, run by Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre at 1 site in Bahrain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Supraventricular
- What is being tested?
- Electrophysiology Study and Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteBahrain
- Study dates
- 20 Jan 2021to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female patients ≥ 18 years of age, indicated for supraventricular arrhythmias ablation according to the current local applicable guidelines
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bahrain1 site, 1 recruiting
- Recruiting
Mohamed Bin Khalifa Cardiac Center
Riffa
MOHAMMAD AMIN, 17767739, drmohdamin@gmail.com
About this study
Official title: 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.
- Conditions
- Tachycardia, Supraventricular
- Being tested
- Electrophysiology Study and Ablation
- Keywords
- Supraventricular tachycardia, Radiation exposure
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiology Study and AblationProcedure or surgery
Electrophysiology Study and Ablation of Supraventricular Arrhythmias
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The day of performing the procedure
Incidence of procedure related cardiac Adverse Events (Safety)
Cardiac related serious adverse events frequency during and after ablation procedure of supraventricular arrhythmias
Measured: 6 months
Secondary outcomes (1)
Fluoroscopy time
Fluoroscopy time during the procedure
Measured: The day of performing the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start20 Jan 2021
- Primary completionSep 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tachycardia, SupraventricularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mohammad Amin, MRCP(UK)FHRS, Principal investigator, Mohamed Bin Khalifa Cardiac Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716270
- Sponsor's protocol ID
- Version 1.0 of 2020-08-05
- Acronym
- AALARA
- Status last verified
- Sep 2022
- First submitted
- 15 Jan 2021
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amin M, Abdrakhmanov A, Kropotkin E, Traykov V, Sallo Z, Geller L, Lorgat F, Sapelnikov O, Toman O, Al-Muti K, Aljaabari M, Bystriansky A, Kornyei L, Mujovic N, Simons S, Szegedi N. Ablation of Supraventricular Arrhythmias With as Low as Reasonably Achievable X-Ray exposure (AALARA): Results of Prospective, Observational, Multicenter, Multinational, Open-Label Registry Study on Real World Data Using Routine Ensite 3D Mapping During SVT Ablation. Pacing Clin Electrophysiol. 2024 Nov;47(11):1441-1448. doi: 10.1111/pace.15075. Epub 2024 Sep 27.
PubMed 39331462Szegedi N, Kroptkin E, Traykoc V, Abdrakhmanov A, Lorgat F, Sapelnikov O, Simons S, Amin M. Routine use of a 3D mapping system in the ablation of supraventricular arrhythmias with as low as reasonably achievable X-ray exposure (AALARA): protocol for a prospective, observational, multicentre, multinational, open-label registry study. BMJ Open. 2023 Aug 4;13(8):e072181. doi: 10.1136/bmjopen-2023-072181.
PubMed 37541748
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation of Supraventricular Arrhythmias With As Low As Reasonably Achievable X-Ray Exposure (AALARA)
- ClinicalTrials.gov ID
- NCT04716270
- Acronym / sponsor ID
- AALARA / Version 1.0 of 2020-08-05
- Conditions
- Tachycardia, Supraventricular
- Keywords
- Supraventricular tachycardia, Radiation exposure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac CentreOther government
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients ≥ 18 years of age, indicated for supraventricular arrhythmias ablation according to the current local applicable guidelines
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrophysiology Study and AblationElectrophysiology Study and Ablation of Supraventricular Arrhythmias | Procedure or surgery | – |
Primary outcome
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
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
1 secondary outcome
Fluoroscopy time
Time frame: The day of performing the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Derived from this study: PubMed 39331462Amin M, Abdrakhmanov A, Kropotkin E, Traykov V, Sallo Z, Geller L, Lorgat F, Sapelnikov O, Toman O, Al-Muti K, Aljaabari M, Bystriansky A, Kornyei L, Mujovic N, Simons S, Szegedi N. Ablation of Supraventricular Arrhythmias With as Low as Reasonably Achievable X-Ray exposure (AALARA): Results of Prospective, Observational, Multicenter, Multinational, Open-Label Registry Study on Real World Data Using Routine Ensite 3D Mapping During SVT Ablation. Pacing Clin Electrophysiol. 2024 Nov;47(11):1441-1448. doi: 10.1111/pace.15075. Epub 2024 Sep 27.
- Derived from this study: PubMed 37541748Szegedi N, Kroptkin E, Traykoc V, Abdrakhmanov A, Lorgat F, Sapelnikov O, Simons S, Amin M. Routine use of a 3D mapping system in the ablation of supraventricular arrhythmias with as low as reasonably achievable X-ray exposure (AALARA): protocol for a prospective, observational, multicentre, multinational, open-label registry study. BMJ Open. 2023 Aug 4;13(8):e072181. doi: 10.1136/bmjopen-2023-072181.
Related trials for Tachycardia, Supraventricular
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
Active, not recruitingPhase 1/2
Treatment of Orthostatic Intolerance
Tachycardia, Chronic Orthostatic Intolerance
Not yet recruitingObservational study
Cardiac Arrhythmias in Pediatric Emergency Department
Arrhythmias, Cardiac, Tachycardia, Supraventricular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Amin, MRCP(UK)FHRS principal investigator
Mohamed Bin Khalifa Cardiac Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tachycardia, Supraventricular, run by Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre at 1 site in Bahrain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bahrain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MOHAMMAD AMIN (0097317767739, drmohdamin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation exposure dose (time frame: The day of performing the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04716270, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.