Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation

NCT02137798 | Completed DMC

• 2 other identifiers: EK474122013CARTOUNIVU
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

fluoroscopy exposure; paroxysmal atrial fibrillation Ablation; fluoroscopy; Atrial Fibrillation Ablation

Outcome Measures

Primary Outcomes (2)

• Fluoroscopy time for 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.

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

• Fluoroscopy doses for 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.

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

Secondary Outcomes (3)

• Number of patients with adverse events as a measure of safety

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

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

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

• Total time of atrial fibrillation ablation procedure as a measure of efficacy

  up to 24 hours

Study Arms (2)

CARTOUNIVU

EXPERIMENTAL

Radiofrequency catheter ablation of atrial fibrillation will be performed using fluoroscopy image integrated 3-dimentional electroanatomical mapping system

Device: Radio-frequency catheter ablation

CARTO3

ACTIVE COMPARATOR

Radiofrequency catheter ablation of atrial fibrillation will be performed using 3-dimentional electroanatomical mapping system without fluoroscopy image integration technique

Device: Radio-frequency catheter ablation

Interventions

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.

CARTO3; CARTOUNIVU

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

Department of Electrophysiology, University of Dresden - Heart Center

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher Piorkowski, M.D.

  Department of Electrophysiology, University of Dresden - Heart Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 14, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 9, 2014

Record last verified: 2014-10

Locations

DE (1)