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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04379557
• Other study ID #: LESS AF
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: November 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National university Hostpital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	any atrial fibrillation/atrial tachycardia recurrence	detected by 12-lead electrocardiogram or 24-hour holter monitoring	1-year after index procedure
Secondary	Total time	Total ablation time, fluoroscopic time, and procedure time	during procedure
Secondary	Rate of Complication	Complications associated with procedure.(bleeding, cardiac tamponade, etc.)	1 year