Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation

NCT ID: NCT02137798

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-09-30

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

Detailed Description

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CARTOUNIVU

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

Group Type: EXPERIMENTAL

Radio-frequency catheter ablation

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Radio-frequency catheter ablation

Intervention Type: 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.

Interventions

Radio-frequency catheter ablation

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Christopher Piorkowski

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Piorkowski, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Electrophysiology, University of Dresden - Heart Center

Locations

Department of Electrophysiology, University of Dresden - Heart Center

Dresden, Saxony, Germany

Countries

Germany

Other Identifiers

CARTOUNIVU

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EK474122013

Identifier Type: -

Identifier Source: org_study_id