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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Catheter Ablation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National university Hostpital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High power ablation

Conventional ablation

Arm 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)

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

Outcomes

Primary Outcome Measures

Ablation time
To compare ablation time of ablation index guided high power ablation for pulmonary vein isolation in patients with atrial fibrillation

Secondary Outcome Measures

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)
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)
any atrial fibrillation/atrial tachycardia recurrence
detected by 12-lead electrocardiogram or 24-hour holter monitoring
Total time
Total ablation time, fluoroscopic time, and procedure time
Rate of Complication
Complications associated with procedure.(bleeding, cardiac tamponade, etc.)

Full Information

First Posted
March 17, 2020
Last Updated
May 4, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04379557
Brief Title
Ablation Index Guided High Power Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation
Official Title
Ablation Index Guided High Power Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High power ablation
Arm Type
Experimental
Arm 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)
Arm Title
Conventional ablation
Arm Type
Active Comparator
Arm Description
Conventional ablation applying 30-35W strategy for Left atrium anterior segments.
Intervention Type
Procedure
Intervention Name(s)
Catheter Ablation
Intervention Description
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
Primary Outcome Measure Information:
Title
Ablation time
Description
To compare ablation time of ablation index guided high power ablation for pulmonary vein isolation in patients with atrial fibrillation
Time Frame
during procedure
Secondary Outcome Measure Information:
Title
residual potential after first pass pulmonary vein encirclement
Description
segment which observed residual potential after first pass pulmonary vein encirclement during procedure (based on predefined pulmonary vein segments)
Time Frame
during procedure
Title
acute pulmonary vein reconnection
Description
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)
Time Frame
1 year
Title
any atrial fibrillation/atrial tachycardia recurrence
Description
detected by 12-lead electrocardiogram or 24-hour holter monitoring
Time Frame
1-year after index procedure
Title
Total time
Description
Total ablation time, fluoroscopic time, and procedure time
Time Frame
during procedure
Title
Rate of Complication
Description
Complications associated with procedure.(bleeding, cardiac tamponade, etc.)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Euekeun Choi, M.D. Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National university Hostpital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34621423
Citation
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.
Results Reference
derived

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

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