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

Seoul National University

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: Catheter Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04379557

LESS AF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

High power ablation

Experimental group

Description:

Ablation Index guided high power ablation (radio frequency energy: Left atrium anterior segment and roof: 40W, Left atrium inferior/posterior: 30W, near esophagus: 25W)

Treatment:

Procedure: Catheter Ablation

Conventional ablation

Active Comparator group

Description:

Conventional ablation applying 30-35W strategy for Left atrium anterior segments.

Treatment:

Procedure: Catheter Ablation