Atrial FibrillationNCT03389074
Evaluation of Optimal Ablation Index for Pulmonary Vein Isolation in Patients With AF Prospective Registry
An observational study of Atrial Fibrillation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In this study, the investigators identify the optimal AI value for achieving good acute outcomes in PVI. Through the Phase 1 study, the investigators will prospectively analyze data including ablation parameters, AI and acute outcomes of 20 patients performed PVI with conventional ablation strategy (AI-blinded). Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Radiofrequency catheter ablation
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jan 2017to 31 Dec 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Korean
Who may be able to join
- 20 to 80 years old
- Patients with symptomatic paroxysmal or persistent AF who had failed with anti-arrhythmic agents
Who cannot join
- Patients who had previous ablation for AF
- Patients with left atrial (LA) diameter more than 50mm
- Inability or unwillingness to receive oral anticoagulation with a Vitamin K antagonist (VKA)or non-VKA (NOAC) agent
- Known severe left ventricular systolic function (ejection fraction<35%)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of OPTIMal Ablation Index for pUlMonary Vein Isolation in Patients With Atrial Fibrillation (OPTIMUM) Prospective Registry
In this study, the investigators identify the optimal AI value for achieving good acute outcomes in PVI.
Through the Phase 1 study, the investigators will prospectively analyze data including ablation parameters, AI and acute outcomes of 20 patients performed PVI with conventional ablation strategy (AI-blinded).
After Phase 1 study results, optimal target AI value for each predefined PV segment will be determined. Then, by applying optimal AI values derived from the Phase 1 study, the investigators will evaluate the feasibility of the AI-guided procedure and verify the optimal AI value for acute PVI outcomes in the prospectively enrolled patients (n = 30) in the Phase 2 study.
Read the detailed description
- Phase 1 A total of 30 240 patients with AF will be prospectively and consecutively enrolled and applied conventional ablation strategy with AI-blinded using contact force sensing catheter (Thermocool SmartTouch Catheter, Biosense Webster Inc.). Conventional ablation will be performed signal reduction-guided, point by point ablation using Visitag automated annotation criteria (2520-35W, target contact force 10-20g30g, target time: 30-40sec for anterior/roof segments, 2015-30sec for posterior/inferior segments). AI value will be derived from comprehensive off-line analysis of ablation parameters including contact force, time, power and AI of these 30 240 patients by predefined 14 segments. Through comparison of AI of each segment with or without acute outcomes including PV residual potential after first encirclement/early reconnection (ER)/dormant conduction (DC), minimal AI value would be drawndetermined, and optimal AI value will be suggested for future AI-guided ablation strategy Phase 2 study (AI-guided ablation strategy).
- Phase 2 The Phase 2 study aims to evaluate the feasibility of applying optimal AI values derived from the Phase 1 study, and to verify optimal values through AI-guided ablation. Thirty patients with AF will be prospectively and consecutively enrolled. AI information will be opened to the operator during ablation, and Visitag annotation criteria will also be used for AI-guided ablation with pre-set minimum target values for each segment derived from the Phase 1 study. After the procedure, the proportion of ablation points within the target AI value will be calculated by evaluation of the feasibility of the AI-guided ablation strategy. Acute outcomes of PVI including PV residual potential after first encirclement, ER, and DC will be evaluated based on predefined segments.
- Comparison of conventional vs. AI-guided ablation The investigators will compare the acute outcomes of PVI using two different strategies: conventional vs. AI-guided ablation. During 1 year of follow-up in both groups, AF recurrence will be evaluated at 3, 6, 9 and 12 months using rhythm surveillance (ECG or 24-hour Holter monitoring). The AF recurrence rate at 1 year after PVI will be compared between the two groups. In addition, total ablation time, fluoroscopic time, procedure time, and complication rates for the index procedure will be compared between the two groups.
- Conditions
- Atrial Fibrillation
- Being tested
- Radiofrequency 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.
Radiofrequency catheter ablationProcedure or surgery
minimally-invasive procedure used to remove or terminate a faulty electrical pathway from sections of the hearts of those who are prone to developing cardiac arrhythmias.
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of a-fib
Early recurrence and late recurrence(after 1-year)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start23 Jan 2017
- Primary completion9 Sep 2019
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eue-Keun Choi, Seoul National University Hospital
- Investigators
- Euekeun Choi, M.D. Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389074
- Sponsor's protocol ID
- OPTIMUM
- Status last verified
- Mar 2020
- First submitted
- 3 Nov 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SR, Choi EK, Lee EJ, Choe WS, Cha MJ, Oh S. Efficacy of the optimal ablation index-targeted strategy for pulmonary vein isolation in patients with atrial fibrillation: the OPTIMUM study results. J Interv Card Electrophysiol. 2019 Aug;55(2):171-181. doi: 10.1007/s10840-019-00565-4. Epub 2019 May 17.
PubMed 31102113
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of OPTIMal Ablation Index for pUlMonary Vein Isolation in Patients With Atrial Fibrillation (OPTIMUM) Prospective Registry
- ClinicalTrials.gov ID
- NCT03389074
- Acronym / sponsor ID
- OPTIMUM
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 Jan 2018 (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.
In this study, the investigators identify the optimal AI value for achieving good acute outcomes in PVI.
Through the Phase 1 study, the investigators will prospectively analyze data including ablation parameters, AI and acute outcomes of 20 patients performed PVI with conventional ablation strategy (AI-blinded).
After Phase 1 study results, optimal target AI value for each predefined PV segment will be determined. Then, by applying optimal AI values derived from the Phase 1 study, the investigators will evaluate the feasibility of the AI-guided procedure and verify the optimal AI value for acute PVI outcomes in the prospectively enrolled patients (n = 30) in the Phase 2 study.
Detailed description
- Phase 1 A total of 30 240 patients with AF will be prospectively and consecutively enrolled and applied conventional ablation strategy with AI-blinded using contact force sensing catheter (Thermocool SmartTouch Catheter, Biosense Webster Inc.). Conventional ablation will be performed signal reduction-guided, point by point ablation using Visitag automated annotation criteria (2520-35W, target contact force 10-20g30g, target time: 30-40sec for anterior/roof segments, 2015-30sec for posterior/inferior segments). AI value will be derived from comprehensive off-line analysis of ablation parameters including contact force, time, power and AI of these 30 240 patients by predefined 14 segments. Through comparison of AI of each segment with or without acute outcomes including PV residual potential after first encirclement/early reconnection (ER)/dormant conduction (DC), minimal AI value would be drawndetermined, and optimal AI value will be suggested for future AI-guided ablation strategy Phase 2 study (AI-guided ablation strategy).
- Phase 2 The Phase 2 study aims to evaluate the feasibility of applying optimal AI values derived from the Phase 1 study, and to verify optimal values through AI-guided ablation. Thirty patients with AF will be prospectively and consecutively enrolled. AI information will be opened to the operator during ablation, and Visitag annotation criteria will also be used for AI-guided ablation with pre-set minimum target values for each segment derived from the Phase 1 study. After the procedure, the proportion of ablation points within the target AI value will be calculated by evaluation of the feasibility of the AI-guided ablation strategy. Acute outcomes of PVI including PV residual potential after first encirclement, ER, and DC will be evaluated based on predefined segments.
- Comparison of conventional vs. AI-guided ablation The investigators will compare the acute outcomes of PVI using two different strategies: conventional vs. AI-guided ablation. During 1 year of follow-up in both groups, AF recurrence will be evaluated at 3, 6, 9 and 12 months using rhythm surveillance (ECG or 24-hour Holter monitoring). The AF recurrence rate at 1 year after PVI will be compared between the two groups. In addition, total ablation time, fluoroscopic time, procedure time, and complication rates for the index procedure will be compared between the two groups.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Korean
Key inclusion criteria (2 listed)
- 20 to 80 years old
- Patients with symptomatic paroxysmal or persistent AF who had failed with anti-arrhythmic agents
Key exclusion criteria (5 listed)
- Patients who had previous ablation for AF
- Patients with left atrial (LA) diameter more than 50mm
- Inability or unwillingness to receive oral anticoagulation with a Vitamin K antagonist (VKA)or non-VKA (NOAC) agent
- Known severe left ventricular systolic function (ejection fraction<35%)
- Pregnancy
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 |
|---|---|---|
| Radiofrequency catheter ablationminimally-invasive procedure used to remove or terminate a faulty electrical pathway from sections of the hearts of those who are prone to developing cardiac arrhythmias. | Procedure or surgery | – |
Primary outcome
recurrence of a-fib
Time frame: 1 year
Early recurrence and late recurrence(after 1-year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Derived from this study: PubMed 31102113Lee SR, Choi EK, Lee EJ, Choe WS, Cha MJ, Oh S. Efficacy of the optimal ablation index-targeted strategy for pulmonary vein isolation in patients with atrial fibrillation: the OPTIMUM study results. J Interv Card Electrophysiol. 2019 Aug;55(2):171-181. doi: 10.1007/s10840-019-00565-4. Epub 2019 May 17.
- Individual participant dataSharing planned: No
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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.
Euekeun Choi, M.D. Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Seoul National University Hospital 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 2 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 18 Mar 2020. 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?
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?
recurrence of a-fib (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03389074, which also lists 1 linked publication.
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 18 Mar 2020.