- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02364401
Impedance vs. Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System
Comparison of Efficacy Between Impedance Guided and Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System
Study Overview
Detailed Description
During atrial fibrillation ablation, the location where ablation is conducted is displayed through annotation tags using 3D system to recognize energy delivery is done at the area. However this annotation method was unable to identify how effectively the ablation is done. To remedy this disadvantage, automated annotation system (VisiTag™ module, Biosense Webster, Inc., Diamond Bar, CA) was recently developed to make an automatic annotation when all pre-defined criteria are satisfied. But study on the clinical effects of this system is insufficient.
The purpose of this study is to compare the efficacy of catheter ablation for atrial fibrillation between contact force-guided and impedance-guided annotation using automated annotation system.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Daegu, Korea, Republic of, 700-712
- Keimyung University Dongsan Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with non-valvular atrial fibrillation
- Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
- Patients with tachycardia-bradycardia syndrome associated with atrial fibrillation.
- Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them
- Patients who are available of follow-up at least for more than three months after catheter ablation
Exclusion Criteria:
- Patients unsuitable for catheter ablation because the size of left atrium is over 5.5cm
- Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.
- Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation
- Patients in the subject group vulnerable to clinical study
- Patients who had undergone a prior catheter ablation for atrial fibrillation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Impedance Guided Ablation Group
Impedance guided ablation group performs pulmonary vein(PV) isolation guided by annotation criteria with minimum time of 10 seconds, maximum range of 2 mm, and minimum impedance decrease over 5 Ohms instead of CF parameters.
In the impedance guided group, operators are blinded to contact force data during PV isolation.
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Catheter ablation for atrial fibrillation
Other Names:
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ACTIVE_COMPARATOR: Contact Forced Guided Ablation Group
Contact force(CF) guided ablation group performs pulmonary vein (PV) isolation guided by automated annotation criteria with minimum time of 10 seconds, maximum range of 2mm, CF over time of 50% and minimum CF of 10 g.
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Catheter ablation for atrial fibrillation
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute success rate of pulmonary vein isolation obtained after initial circumferential ablation line around pulmonary veins
Time Frame: 6 hours
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Acute success is defined as confirmation of entrance block in all pulmonary veins
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6 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrence of any atrial arrhythmias (atrial fibrillation or atrial tachycardia)
Time Frame: 12 months
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12 months
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Procedure time
Time Frame: 6 hours
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6 hours
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Ablation time
Time Frame: 6 hours
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6 hours
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Average contact force of each ablation lesion
Time Frame: 6 hours
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6 hours
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Impedance drop of each ablation lesion
Time Frame: 6 hours
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6 hours
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Force time integral of each ablation lesion
Time Frame: 6 hours
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6 hours
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSMCEP_PHS_001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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