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Completed

NCT Number: NCT02137798

Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation

To evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation in patients with paroxysmal atrial fibrillation using fluoroscopy image integrated 3-dimentional electroanatomical mapping system, comparing to using 3-dimentional electroanatomical mapping system without fluoroscopy image integration

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Electrophysiology, University of Dresden - Heart Center

Dresden, Saxony, 01307, Germany

About this study

The novel fluoroscopic image integrated 3-dimentional electroanatomical mapping system is designed for minimizing the exposure to X-ray for physician, staff and patients. This randomized single-center study is to evaluate the reduction on fluoroscopy levels (time and dosis) in catheter interventional treatment of symptomatic, antiarrhythmic refractory paroxysmal atrial fibrillation using fluoroscopic image integrated 3-dimentional electroanatomical mapping system, comparing with using 3-dimentional electroanatomical mapping system without fluoroscopic image integration. Patients with documented paroxysmal atrial fibrillation, who are going to receive a catheter interventional treatment to atrial fibrillation, will be randomized (1:1) into two groups after signing an informed consent. Group 1 (CARTOUNIVU): using fluoroscopic image integrated 3-dimentional electroanatomical mapping system. Group 2 (CARTO3): using 3-dimentional electroanatomical mapping system without fluoroscopic image integration.

The ablation strategies in both study groups are the same, including circumferential isolation of ipsilateral pulmonary veins (PV) and voltage map guided substrate modification. According to the randomization, the ablation procedure will be performed with or without fluoroscopic image integration.

The primary endpoint of this study is the evaluation of reduction on fluoroscopy levels (fluoroscopy time and dosis) during atrial fibrillation ablation procedure. Secondary endpoints include complete isolation of the pulmonary veins, completely bidirectional block of linear ablation lines, total procedure time, ablation-related complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • documented atrial fibrillation in the 12-lead ECG or Holter ECG
  • Paroxysmal symptomatic atrial fibrillation
  • Ineffectiveness of antiarrhythmic medication ( at least 1 medication )
  • Age 18-75 years
  • left atrial diameter <60 mm ( Transesophageal Echocardiography, parasternal )
  • A signed consent form

Exclusion criteria

  • Reversible etiology of atrial fibrillation
  • Pregnancy
  • Women of childbearing potential without a negative pregnancy test within 48 hours prior to the ablation procedure
  • Intracardiac thrombus
  • Contraindication to anticoagulation
  • Thromboembolic event in the last 6 months
  • Previous left atrial ablation

Treatment and study plan

Radio-frequency catheter ablation

Device

Radio-frequency atrial fibrillation catheter ablation includes circumferential PV isolation and voltage-map guided substrate modification, which means low voltage zone (amplitude < o.5 mV) will also be ablated.

Primary outcomes

  1. Fluoroscopy time for each step of atrial fibrillation ablation procedure

    Time frame: 1 day ( at the end of each step of atrial fibrillation ablation procedure)

    Fluoroscopy time will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations.

  2. Fluoroscopy doses for each step of atrial fibrillation ablation procedure

    Time frame: 1 day ( at the end of each step of atrial fibrillation ablation procedure)

    Fluoroscopy doses will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations.

Secondary outcomes

  1. Number of patients with adverse events as a measure of safety

    Time frame: All patients will be followed for the duration of hospital stay for acute complications, an expected average of 3 days.

    Perforation, tamponed, phrenic nerve injury and oesophagus injury (patients will be screened for oesophagus injury for a month after atrial fibrillation ablation), etc.

  2. Number of patients with a failure of reaching endpoints of procedure as a measure of efficacy

    Time frame: 1 day ( at the end of each step of atrial fibrillation ablation procedure)

    number of pulmonary veins/linear ablation lines has not been completely isolated/blocked at the end of the AF ablation

  3. Total time of atrial fibrillation ablation procedure as a measure of efficacy

    Time frame: up to 24 hours

    procedure time (minute)

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Biosense Webster, Inc.

Registry information

Official study title

Atrial Fibrillation Ablation Facilitated by Fluoroscopy Image Integrated 3-dimentional Electroanatomical Mapping System

Acronym: AF-FII

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 14, 2014
Registry last updated
Oct 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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