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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Catheter Ablation

• Registration Number: NCT04379557
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2018-10-30
• Status Verified: 2019-11
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-05-04
• Last Update Submitted: 2020-05-04
• Study First Posted: 2020-05-07
• Last Update Posted: 2020-05-07
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional ablation	Catheter Ablation	Conventional ablation applying 30-35W strategy for Left atrium anterior segments.
High power ablation	Catheter 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)

Primary Outcome Measures

Name	Time	Method
Ablation time	during procedure	To compare ablation time of ablation index guided high power ablation for pulmonary vein isolation in patients with atrial fibrillation

Secondary Outcome Measures

Name	Time	Method
Total time	during procedure	Total ablation time, fluoroscopic time, and procedure time
residual potential after first pass pulmonary vein encirclement	during procedure	segment which observed residual potential after first pass pulmonary vein encirclement during procedure (based on predefined pulmonary vein segments)
acute pulmonary vein reconnection	1 year	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)
any atrial fibrillation/atrial tachycardia recurrence	1-year after index procedure	detected by 12-lead electrocardiogram or 24-hour holter monitoring
Rate of Complication	1 year	Complications associated with procedure.(bleeding, cardiac tamponade, etc.)

Trial Locations

Locations (1)

Seoul National university Hostpital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of