Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Prospective Randomized Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02171364
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Radiofrequency catheter ablation is highly effective in the treatment of patients with persistent atrial fibrillation. In order to decrease the recurrence rate after catheter ablation, the investigators propose to apply 'virtual' ablation on patient-specific atria by simulating 3D atrial computer model. The investigators will test with five different set of ablation methods and find successful methods for a specific patient. Then, this result will be compared to empirical catheter ablation result by randomly controlled trial.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Virtual ablation in based 3D CT of patient who diagnosed AF Procedure: conventional ablation based on physician's personal experience Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : August 2014
Actual Primary Completion Date : September 1, 2015
Actual Study Completion Date : September 1, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: virtual simulation
This intervention group is to choose the best effective method operation to patients by simulating 3D atrial computer model which consider patient's heart size and shape.
Procedure: Virtual ablation in based 3D CT of patient who diagnosed AF
Active Comparator: conventional ablation
The other intervention group is to operate the atrial fibrillation by physician's personal experience, not by virtual simulation.
Procedure: conventional ablation based on physician's personal experience



Primary Outcome Measures :
  1. change of hospitalization rate [ Time Frame: 1, 3, 6, 12, 18 and 24 months after catheter ablation and every 6 months thereafter. ]

Secondary Outcome Measures :
  1. occurence of cardiovascular disease [ Time Frame: 6 months ]
  2. recurrence of AF [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of AF patients who performed catheter ablation of atrial fibrillation due to uncontrolled pulse rate by anti-arrhythmic drug therapy.

Exclusion Criteria:

  • AF patients who have severe heart deformations or blood problems.
  • The patients who had been performed catheter ablation of atrial ablation.
  • The patients who missed out to recording of 3D CT, echo and electrocardiography.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171364


Locations
Layout table for location information
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02171364    
Other Study ID Numbers: 4-2013-0536
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Keywords provided by Yonsei University:
Atrial fibrillation, Virtual ablation, electrocardiography, electroanatomical mapping data
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes