Impedance vs. Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System
NCT ID: NCT02364401
Last Updated: 2017-08-21
Study Results
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.
COMPLETED
NA
50 participants
INTERVENTIONAL
2015-02-28
2016-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
AF Ablation Based on High Density Voltage Mapping and CFAE
NCT03046043
Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation
NCT01851525
Ultra-High-Resolution Mapping Guided Partial Antral Ablation for AF
NCT03759912
Use of a Novel Contact Force Sensing Catheter for AF Ablation - Impact of TactiCath on Dormant Conduction Across the Pulmonary Veins
NCT02666729
TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study
NCT02310100
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Ablation
Catheter ablation for atrial fibrillation
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.
Ablation
Catheter ablation for atrial fibrillation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ablation
Catheter ablation for atrial fibrillation
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
20 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biosense Webster, Inc.
INDUSTRY
Keimyung University Dongsan Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hyoung-Seob Park, MD
Role: PRINCIPAL_INVESTIGATOR
Keimyung University Dongsan Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DSMCEP_PHS_001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.