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Evaluation of Optimal Ablation Index for Pulmonary Vein Isolation in Patients With AF Prospective Registry

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ClinicalTrials.gov Identifier: NCT03389074
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Eue-Keun Choi, Seoul National University Hospital

Brief Summary:

In this study, we identify the optimal AI value for achieving good acute outcomes in PVI.

Through the Phase 1 study, we 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, we 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.


Condition or disease Intervention/treatment
Atrial Fibrillation Procedure: Radiofrequency catheter ablation

Detailed Description:
  1. 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 (Figure 1).

    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 strategyPhase 2 study (AI-guided ablation strategy).

  2. 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.
  3. Comparison of conventional vs. AI-guided ablation We 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 Type : Observational [Patient Registry]
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Evaluation of OPTIMal Ablation Index for pUlMonary Vein Isolation in Patients With Atrial Fibrillation (OPTIMUM) Prospective Registry
Actual Study Start Date : January 23, 2017
Estimated Primary Completion Date : January 22, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: Radiofrequency catheter ablation
    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.


Primary Outcome Measures :
  1. recurrence of a-fib [ Time Frame: 1 year ]
    Early recurrence and late recurrence(after 1-year)



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Korean
Criteria

Inclusion Criteria:

  • 20 to 80 years old
  • Patients with symptomatic paroxysmal or persistent AF who had failed with anti-arrhythmic agents

Exclusion Criteria:

  • 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

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): NCT03389074


Contacts
Contact: Euekeun Choi, M.D. Ph.D. 82+02-2072-0688 choiek417@gmail.com

Locations
Korea, Republic of
Seoul National university Hostpital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Euekeun Choi, M.D. Ph.D.    82+02-2072-0688    choiek417@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Euekeun Choi, M.D. Ph.D. Seoul National University Hospital

Responsible Party: Eue-Keun Choi, Associate Professor, MD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03389074     History of Changes
Other Study ID Numbers: OPTIMUM
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes