Atrial FibrillationINVENTIONNCT03989726
Efficacy of High Density Voltage and Fractionation Map Guided Ablation in Patients With Atrial Fibrillation
A study testing AF 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 evaluate the efficacy of high density voltage and fractionation map guided ablation compared to anatomy-based circumferential pulmonary vein Isolation in patients with atrial fibrillation 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?
- AF ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2019to 31 May 2021
- 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
- 1. Age over 20 years old and under 80 years old 2. Patients with non-valvular atrial fibrillation 3. Patients having AF even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks 4. Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them 5. 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 6.0 cm
- 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, 1 recruiting
- Recruiting
Keimyung University Dongsan Hospital
Daegu, 42602
Hyoung-Seob Park, MD, 82532507473, drparkgyver@gmail.com
Hyoung-Seob Park, MD
About this study
Official title: Efficacy of High Density Voltage and Fractionation Map Guided Ablation Compared to Anatomy-based Circumferential Pulmonary Vein Isolation in Patients With Atrial Fibrillation
The purpose of this study is to evaluate the efficacy of high density voltage and fractionation map guided ablation compared to anatomy-based circumferential pulmonary vein Isolation in patients with atrial fibrillation
Read the detailed description
In this study, a test group includes those who undergoing atrial fibrillation(AF) ablation guided by high density voltage and fractionation map. A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential pulmonary vein (PV) isolation.
- Conditions
- Atrial Fibrillation
- Being tested
- AF 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.
AF ablationProcedure or surgery
AF ablation includes pulmonary vein isolation and/or voltage and fractionation guided ablation
| Study group | Role | What they receive |
|---|---|---|
| High density voltage and fractionation map guided group | Experimental | * Complex fractionated atrial electrogram (CFAE), voltage and fractionation map will be performed with a multielectrode mapping catheter.
* The mapping should be performed in AF.
* First, low-voltage zone is defined as an area with bipolar peak-to-peak voltage amplitudes < 0.5mV.
* A voltage-map guided segmental PV isolation is performed. Radiofrequency energy is applied in the antral regions of the PVs. High voltage zone over 0.5mV in the antral region is targeted. IF PV isolation in not achieved by voltage-guided segmental ablation, additional Lasso catheter guided segmental antral ablation is performed.
* Radiofrequency energy is delivered at target sites for 15-30 sec guided by contact force, lesion size index (LSI) and local electrogram elimination.
* If the patient is still in AF after PV isolation, additional fractionation map guided ablation is performed. The fractionation area within low voltage area (<0.5mV) should be targeted. Receives: Procedure: AF ablation |
| Circumferential PV isolation | Active comparator | A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential PV isolation. Receives: Procedure: AF ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free from atrial arrhythmia at 12 months
Freedom from any atrial arrhythmia lasting longer than 30 seconds during 1 year follow-up after single ablation with or without the use of antiarrhythmic medications with the exclusion of the 3-month blanking period.
Measured: 12 months
Secondary outcomes (3)
Acute AF termination rate during the procedure
Acute AF termination rate during the procedure
Measured: During the procedure
Complication rate
Compare complication rate between two groups
Measured: 12 months
Total procedure time, ablation time, fluoroscopy time
Total procedure time, ablation time, fluoroscopy time between two groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Jul 2019
- Primary completion28 Feb 2021 (estimated)
- Study completion31 May 2021 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989726
- Sponsor's protocol ID
- DSMCEP_PHS_003
- Acronym
- INVENTION
- Status last verified
- Jun 2019
- First submitted
- 14 Jun 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Density Voltage and Fractionation Map Guided Ablation Compared to Anatomy-based Circumferential Pulmonary Vein Isolation in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03989726
- Acronym / sponsor ID
- INVENTION / DSMCEP_PHS_003
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 18 Jun 2019 (actual)
- 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 evaluate the efficacy of high density voltage and fractionation map guided ablation compared to anatomy-based circumferential pulmonary vein Isolation in patients with atrial fibrillation
Detailed description
In this study, a test group includes those who undergoing atrial fibrillation(AF) ablation guided by high density voltage and fractionation map. A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential pulmonary vein (PV) isolation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High density voltage and fractionation map guided group | Experimental | Procedure: AF ablation* Complex fractionated atrial electrogram (CFAE), voltage and fractionation map will be performed with a multielectrode mapping catheter. * The mapping should be performed in AF. * First, low-voltage zone is defined as an area with bipolar peak-to-peak voltage amplitudes < 0.5mV. * A voltage-map guided segmental PV isolation is performed. Radiofrequency energy is applied in the antral regions of the PVs. High voltage zone over 0.5mV in the antral region is targeted. IF PV isolation in not achieved by voltage-guided segmental ablation, additional Lasso catheter guided segmental antral ablation is performed. * Radiofrequency energy is delivered at target sites for 15-30 sec guided by contact force, lesion size index (LSI) and local electrogram elimination. * If the patient is still in AF after PV isolation, additional fractionation map guided ablation is performed. The fractionation area within low voltage area (<0.5mV) should be targeted. |
| Circumferential PV isolation | Active comparator | Procedure: AF ablationA control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential PV isolation. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age over 20 years old and under 80 years old 2. Patients with non-valvular atrial fibrillation 3. Patients having AF even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks 4. Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them 5. 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 6.0 cm
- 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 |
|---|---|---|
| AF ablationAF ablation includes pulmonary vein isolation and/or voltage and fractionation guided ablation | Procedure or surgery | Circumferential PV isolation, High density voltage and fractionation map guided group |
Primary outcome
Free from atrial arrhythmia at 12 months
Time frame: 12 months
Freedom from any atrial arrhythmia lasting longer than 30 seconds during 1 year follow-up after single ablation with or without the use of antiarrhythmic medications with the exclusion of the 3-month blanking period.
3 secondary outcomes
Acute AF termination rate during the procedure
Time frame: During the procedure
Complication rate
Time frame: 12 months
Total procedure time, ablation time, fluoroscopy time
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
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
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF 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 1 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: status not confirmed, as of the sponsor's last update on 20 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyoung-Seob Park, MD (+82-53-258-7725, drparkgyver@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free from atrial arrhythmia at 12 months (time frame: 12 months). 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 20 Aug 2019.