Atrial FibrillationNCT02364401
Impedance vs. Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System
A study testing Ablation in people with Atrial Fibrillation, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
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 (Visitag™). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2015to 15 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Keimyung University Dongsan Medical Center
Daegu, 700-712
About this study
Official title: Comparison of Efficacy Between Impedance Guided and Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System
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 (Visitag™). Patients who receive atrial fibrillation ablation are randomly assigned in the same number to two groups with impedance guided ablation and contact force guided ablation using contact force sensing catheter (THERMOCOOL® SMARTTOUCH™ catheter, Biosense Webster, Inc., Diamond Bar, CA).
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Ablation
- Keywords
- Atrial Fibrillation, Catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationDevice
Also called THERMOCOOL® SMARTTOUCH™ catheter
Catheter ablation for atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Impedance Guided Ablation Group | Experimental | 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. Receives: Device: Ablation |
| Contact Forced Guided Ablation Group | Active comparator | 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. Receives: Device: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute success rate of pulmonary vein isolation obtained after initial circumferential ablation line around pulmonary veins
Acute success is defined as confirmation of entrance block in all pulmonary veins
Measured: 6 hours
Secondary outcomes (6)
Recurrence of any atrial arrhythmias (atrial fibrillation or atrial tachycardia)
Measured: 12 months
Procedure time
Measured: 6 hours
Ablation time
Measured: 6 hours
Average contact force of each ablation lesion
Measured: 6 hours
Impedance drop of each ablation lesion
Measured: 6 hours
Force time integral of each ablation lesion
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completion15 Nov 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
- Investigators
- Hyoung-Seob Park, MD, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364401
- Sponsor's protocol ID
- DSMCEP_PHS_001
- Status last verified
- Aug 2016
- First submitted
- 30 Jan 2015
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy Between Impedance Guided and Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System
- ClinicalTrials.gov ID
- NCT02364401
- Acronym / sponsor ID
- DSMCEP_PHS_001
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Catheter ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- Feb 2015
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (Visitag™). Patients who receive atrial fibrillation ablation are randomly assigned in the same number to two groups with impedance guided ablation and contact force guided ablation using contact force sensing catheter (THERMOCOOL® SMARTTOUCH™ catheter, Biosense Webster, Inc., Diamond Bar, CA).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impedance Guided Ablation Group | Experimental | Device: AblationImpedance 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. |
| Contact Forced Guided Ablation Group | Active comparator | Device: AblationContact 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AblationAlso: THERMOCOOL® SMARTTOUCH™ catheterCatheter ablation for atrial fibrillation | Device | Contact Forced Guided Ablation Group, Impedance Guided Ablation Group |
Primary outcome
Acute success rate of pulmonary vein isolation obtained after initial circumferential ablation line around pulmonary veins
Time frame: 6 hours
Acute success is defined as confirmation of entrance block in all pulmonary veins
6 secondary outcomes
Recurrence of any atrial arrhythmias (atrial fibrillation or atrial tachycardia)
Time frame: 12 months
Procedure time
Time frame: 6 hours
Ablation time
Time frame: 6 hours
Average contact force of each ablation lesion
Time frame: 6 hours
Impedance drop of each ablation lesion
Time frame: 6 hours
Force time integral of each ablation lesion
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyoung-Seob Park, MD principal investigator
Keimyung University Dongsan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in people with Atrial Fibrillation, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute success rate of pulmonary vein isolation obtained after initial circumferential ablation line around pulmonary veins (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.