Ablation Index Guided High Power Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation

The investigators will compare the ablation time during pulmonary vein isolation of Ablation Index-guided high power ablation with those with conventional ablation.

Ablation time of conventional group will be used from OPTIMUM study. For secondary outcomes, acute outcomes of pulmonary vein isolation using two different strategies will be compared. During 1 year of follow-up in both groups, atrial fibrillation recurrence will be evaluated. The atrial fibrillation recurrence rate at 1 year after pulmonary vein isolation will be compared between the two groups. In addition, fluoroscopic time, procedure time, and complication rates for the high power ablation group will be compared with those with conventional power.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Catheter Ablation

Detailed Description

Ablation Index guided high power ablation will be performed in 70 patients with atrial fibrillation with prospectively and consecutively. A contact force-sensing catheter will be used. Ablation will be performed with point-by-point technique using Visitag automated annotation criteria as below;

Ablation Index(AI) target:

• Anterior/roof : 450 AI
• Anterior near carina area : 500 AI
• Posterior/inferior/carina : 350 AI
• Posterior near carina area : 400 AI
• Area near esophagus :25W, 15sec or 300 AI (no further ablation if esophageal temperature increase more than 39°C)
• Interlesion distance ≤ 4.5mm

VISITAGTM settings

• 2.5mm stability range
• 7 sec stability time
• FOT 25%, 3g force
• Tag size 2mm

Ablation parameters are preset as below;

• RF power range: 40W at anterior/roof, 30W at posterior/inferior, 25W at near esophagus area (decrease power 5W by operator decision)
• Target contact force range: 10-20 g
• Flow rate:
• 8 ml/min for STSF < 30W
• 15 ml/min for STSF ≥ 30W

Acute reconnection will be analysed according to predefined segments.

Subgroup analysis will be performed according to type of AF. Data of patients with paroxysmal atrial fibrillation and persistent atrial fibrillation will be analysed separately, and investigate whether this new ablation strategy is effective in both group of patients. To compare outcomes with OPITMUM phase 2 study, the proportion of patients with paroxysmal and persistent atrial fibrillation would be 75% and 25%. Therefore, 53 patients with paroxysmal atrial fibrillation and 17 patients with persistent atrial fibrillation will be enrolled in this study.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Seoul National university Hostpital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with symptomatic paroxysmal or persistent AF who failed anti-arrhythmic agents

Exclusion Criteria:

• Patients who had previous ablation for AF
• Patients with left atrial diameter more than 50 mm
• Inability or unwillingness to receive oral anticoagulation with a vitamin K antagonist (VKA) or non-VKA (NOAC) agent
• Known severe left ventricular systolic dysfunction (ejection fraction <35%)
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High power ablation; Ablation Index guided high power ablation (radio frequency energy: Left atrium anterior segment and roof: 40W, Left atrium inferior/posterior: 30W, near esophagus: 25W)	Procedure: Catheter Ablation; Catheter Ablation is a procedure used to remove or terminate a faulty electrical pathway from sections of the hearts of those who are prone to developing cardiac arrhythmias
Active Comparator: Conventional ablation; Conventional ablation applying 30-35W strategy for Left atrium anterior segments.	Procedure: Catheter Ablation; Catheter Ablation is a 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ablation time	To compare ablation time of ablation index guided high power ablation for pulmonary vein isolation in patients with atrial fibrillation	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
residual potential after first pass pulmonary vein encirclement	segment which observed residual potential after first pass pulmonary vein encirclement during procedure (based on predefined pulmonary vein segments)	during procedure
acute pulmonary vein reconnection	segment which observed early re-connection during procedure (based on predefined pulmonary vein segments) time frame: during procedure (20-30 minutes after pulmonary vein isolation)	1 year
any atrial fibrillation/atrial tachycardia recurrence	detected by 12-lead electrocardiogram or 24-hour holter monitoring	1-year after index procedure
Total time	Total ablation time, fluoroscopic time, and procedure time	during procedure
Rate of Complication	Complications associated with procedure.(bleeding, cardiac tamponade, etc.)	1 year

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Euekeun Choi, M.D. Ph.D, Seoul National University Hospital

Publications and helpful links

General Publications

• Lee SR, Park HS, Choi EK, Lee E, Oh S. Acute and long-term efficacy of ablation index-guided higher power shorter duration ablation in patients with atrial fibrillation: A prospective registry. J Arrhythm. 2021 Jul 21;37(5):1250-1259. doi: 10.1002/joa3.12605. eCollection 2021 Oct.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: LESS AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No