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

NCT ID: NCT04716270

Last Updated: 2022-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-20

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tachycardia, Supraventricular

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Electrophysiology Study and Ablation

Electrophysiology Study and Ablation of Supraventricular Arrhythmias

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mohamed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Amin, MRCP(UK)FHRS

Role: PRINCIPAL_INVESTIGATOR

Mohamed Bin Khalifa Cardiac Center

Locations

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Mohamed Bin Khalifa Cardiac Center

Riffa, , Bahrain

Site Status RECRUITING

Countries

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Bahrain

Central Contacts

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MOHAMMAD AMIN

Role: CONTACT

0097317767739

Facility Contacts

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MOHAMMAD AMIN

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39331462 (View on PubMed)

Szegedi 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.

Reference Type DERIVED
PMID: 37541748 (View on PubMed)

Other Identifiers

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Version 1.0 of 2020-08-05

Identifier Type: -

Identifier Source: org_study_id

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