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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Real Zero Fluoroscopy Catheter Ablation.

NCT03458273

Atrial Arrhythmia Ventricular Arrythmia Arrhythmia +1 more

UNKNOWN

Comparison of Rotational Angiography/Electroanatomical Mapping Fusion Versus CT/Electroanatomical Mapping Fusion to Guide AF Ablation

NCT01537237

Atrial Fibrillation Arrhythmia

COMPLETED

Safety and Efficacy of Catheter Ablation of Idiopathic Ventricular Arrhythmias Arising From Cardiac Outflow Tracts

NCT03258112

Ventricular Arrythmia

WITHDRAWN NA

Ultrasound Guyded Venous Puncture for Safe AF Ablation Procedures

NCT06403527

Puncture for Safe Atrial Fibrillation Ablation

RECRUITING NA

Ablation of Focal Activation in Atrial Fibrillation

NCT06402617

Atrial Fibrillation Atrial Fibrillation, Persistent Arrhythmia +2 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Auricular Flutter Radiation Exposure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized study, patients are allocated to 1 of the 2 groups

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fluoroscopy Group

Patient undergoing common flutter (AFL) ablation procedure using conventional X-ray based fluoroscopy for for catheter tracking

Group Type OTHER

conventional X-ray based Fluoroscopy

Intervention Type PROCEDURE

catheter tracking via conventional X-ray based Fluoroscopy

3D Group

Patient undergoing common flutter (AFL) ablation procedure using the low X-ray 3D navigation technique for for catheter tracking

Group Type EXPERIMENTAL

low X-ray 3D navigation technique

Intervention Type PROCEDURE

catheter tracking via low X-ray 3D navigation technique

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

conventional X-ray based Fluoroscopy

catheter tracking via conventional X-ray based Fluoroscopy

Intervention Type PROCEDURE

low X-ray 3D navigation technique

catheter tracking via low X-ray 3D navigation technique

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Sick adult patients with Atrial Flutter arrythmia
* patients able to consent.
* patients scheduled to receive cavotricuspid isthmus ablation treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No