NCT03946280 (DOSIMETRY-AFL) is a NA clinical trial of conventional X-ray based Fluoroscopy in Auricular Flutter, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.

Who is sponsoring NCT03946280?

NCT03946280 is sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.

What drugs are being tested in NCT03946280?

Interventions in NCT03946280: conventional X-ray based Fluoroscopy, low X-ray 3D navigation technique.

What condition does NCT03946280 study?

NCT03946280 studies Auricular Flutter, Radiation Exposure.

Is NCT03946280 still recruiting?

NCT03946280 is currently status unknown. Last updated 16 July 2019.

Last reviewed 2019-07-16 · How we verify

NCT03946280: DOSIMETRY-AFL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry

Status unknown NA Last updated 16 July 2019

What this trial tests

NA trial testing conventional X-ray based Fluoroscopy in Auricular Flutter in 50 participants. Status unknown.

Timeline

1 November 2018

Primary endpoint
1 November 2020

1 November 2020

Quick facts

Lead sponsor	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	50
Start date	1 November 2018
Primary completion	1 November 2020
Estimated completion	1 November 2020
Sites	1 location across Belgium

Drugs / interventions tested

conventional X-ray based Fluoroscopy
low X-ray 3D navigation technique

Conditions studied

Auricular Flutter — all drugs for Auricular Flutter →
Radiation Exposure — all drugs for Radiation Exposure →

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain — full company profile →

Who can join

18 and older, any sex, with Auricular Flutter or Radiation Exposure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Common Flutter ablation technique use low X-ray based three-dimension (3D) navigation for catheter tracking, have become a popular implementation to treat patient's underlying arrhythmia. Compared with fluoroscopy, the gold standard X-ray based method, this recent technique provides the required anatomical information and reduce risk associated with ionizing radiation exposure. Besides Practical Guidelines "as low as reasonably achievable (ALARA) to minimize and normalize radiation exposure had been published so far. The risk of developing acute radiation associated injuries still remains high. In the present study we will compare two groups of patients undergoing into cavotricuspid isthmus (CTI) ablation using either the 3D navigation ("Ensite NavX system") (n = 25) or conventional fluoroscopy (n = 25). Further developing the 3D navigation technique will help to increase safety during the treatment, for both patients and the personnel and increase the success rate during the electrophysiological (EP) interventional procedures.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03946280 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Last refreshed: 16 July 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03946280.

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