NCT04716270

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

September 6, 2022

Status Verified

September 1, 2022

Enrollment Period

1.6 years

First QC Date

January 15, 2021

Last Update Submit

September 2, 2022

Conditions

Tachycardia, Supraventricular

Keywords

Supraventricular tachycardiaRadiation exposure

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Fluoroscopy time

    The day of performing the procedure

Interventions

Electrophysiology Study and AblationPROCEDURE

Electrophysiology Study and Ablation of Supraventricular Arrhythmias

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Bin Khalifa Cardiac Center

Riffa, Bahrain

RECRUITING

Related Publications (2)

  • 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.

    PMID: 39331462DERIVED

  • 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.

    PMID: 37541748DERIVED

MeSH Terms

Conditions

Tachycardia, Supraventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohammad Amin, MRCP(UK)FHRS

    Mohamed Bin Khalifa Cardiac Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MOHAMMAD AMIN

CONTACT

0097317767739drmohdamin@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 20, 2021

Study Start

January 20, 2021

Primary Completion

September 1, 2022

Study Completion

March 1, 2023

Last Updated

September 6, 2022

Record last verified: 2022-09

Locations

BA(1)