Back to resultsUtility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry (DOSIMETRY-AFL)
Primary Purpose
Auricular Flutter, Radiation Exposure
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
conventional X-ray based Fluoroscopy
low X-ray 3D navigation technique
Sponsored by
About this trial
This is an interventional prevention trial for Auricular Flutter focused on measuring ALARA, radiation exposure, Flutter ablation
Eligibility Criteria
Inclusion Criteria:
- Sick adult patients with Atrial Flutter arrythmia
- patients able to consent.
- patients scheduled to receive cavotricuspid isthmus ablation treatment
Exclusion Criteria:
- patients who do not meet inclusion criteria
Sites / Locations
- Cliniques Universitaires St LucRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Fluoroscopy Group
3D Group
Arm Description
Patient undergoing common flutter (AFL) ablation procedure using conventional X-ray based fluoroscopy for for catheter tracking
Patient undergoing common flutter (AFL) ablation procedure using the low X-ray 3D navigation technique for for catheter tracking
Outcomes
Primary Outcome Measures
Number of Participants
two groups and 25 patiens within each group
age
age in years of every patient in the study
Electrophysiology procedure time (EP time)
time the intervention last in minutes
Radiofrecuency ablation time
time radiofrecuency are applied within the EP time in minutes/ seconds
Total Fluoroscopy time
time the patiens receive x ray radiation along the intervention in minutes/ seconds
Time without fluoroscopy
time the patiens do not receive any x ray radiation along the intervention in minutes/ seconds
Dose area product
Global Radiation dose emited by the x-ray tube in mgcm2
Radiation dose TLD in patient (5 TLD)
five thermoluminescent dosimeters are placed on the body of the patient in mgcm2
Radiation dose TLD in operator (3 TLD)
three thermoluminescent dosimeters are placed on the body of the patient in mgcm2
readmission
times the patient is readmitted in the hospital
Secondary Outcome Measures
Full Information
NCT ID
NCT03946280
First Posted
May 8, 2019
Last Updated
July 12, 2019
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03946280
Brief Title
Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry
Acronym
DOSIMETRY-AFL
Official Title
Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auricular Flutter, Radiation Exposure
Keywords
ALARA, radiation exposure, Flutter ablation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized study, patients are allocated to 1 of the 2 groups
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fluoroscopy Group
Arm Type
Other
Arm Description
Patient undergoing common flutter (AFL) ablation procedure using conventional X-ray based fluoroscopy for for catheter tracking
Arm Title
3D Group
Arm Type
Experimental
Arm Description
Patient undergoing common flutter (AFL) ablation procedure using the low X-ray 3D navigation technique for for catheter tracking
Intervention Type
Procedure
Intervention Name(s)
conventional X-ray based Fluoroscopy
Intervention Description
catheter tracking via conventional X-ray based Fluoroscopy
Intervention Type
Procedure
Intervention Name(s)
low X-ray 3D navigation technique
Intervention Description
catheter tracking via low X-ray 3D navigation technique
Primary Outcome Measure Information:
Title
Number of Participants
Description
two groups and 25 patiens within each group
Time Frame
through study completion, an average of 2 year
Title
age
Description
age in years of every patient in the study
Time Frame
at the moment the patient was recruited for the study
Title
Electrophysiology procedure time (EP time)
Description
time the intervention last in minutes
Time Frame
at the moment of the intervention
Title
Radiofrecuency ablation time
Description
time radiofrecuency are applied within the EP time in minutes/ seconds
Time Frame
at the moment of the intervention
Title
Total Fluoroscopy time
Description
time the patiens receive x ray radiation along the intervention in minutes/ seconds
Time Frame
at the moment of the intervention
Title
Time without fluoroscopy
Description
time the patiens do not receive any x ray radiation along the intervention in minutes/ seconds
Time Frame
at the moment of the intervention
Title
Dose area product
Description
Global Radiation dose emited by the x-ray tube in mgcm2
Time Frame
at the moment of the intervention
Title
Radiation dose TLD in patient (5 TLD)
Description
five thermoluminescent dosimeters are placed on the body of the patient in mgcm2
Time Frame
at the moment of the intervention
Title
Radiation dose TLD in operator (3 TLD)
Description
three thermoluminescent dosimeters are placed on the body of the patient in mgcm2
Time Frame
at the moment of the intervention
Title
readmission
Description
times the patient is readmitted in the hospital
Time Frame
within 12 months following the EP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sick adult patients with Atrial Flutter arrythmia
patients able to consent.
patients scheduled to receive cavotricuspid isthmus ablation treatment
Exclusion Criteria:
patients who do not meet inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Scavée, PhD, MD
Phone
+3227642808
Email
christophe.scavee@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Yovan Sanchez Ruiz, PhD
Email
Yovan.sanchezruiz@student.uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Scavée, PhD
Organizational Affiliation
Cliniques Universitaires St Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires St Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yovan SANCHEZ RUIZ
Email
ysanchezruiz@student.uclouvain.be
First Name & Middle Initial & Last Name & Degree
Christophe SCAVEE
Phone
3227642808
Email
christophe.scavee@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Christophe Scavee, Phd, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry
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