NCT04379557

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

May 7, 2020

Status Verified

November 1, 2019

Enrollment Period

2.2 years

First QC Date

March 17, 2020

Last Update Submit

May 4, 2020

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • residual potential after first pass pulmonary vein encirclement

    during procedure

  • acute pulmonary vein reconnection

    1 year

  • any atrial fibrillation/atrial tachycardia recurrence

    1-year after index procedure

  • Total time

    during procedure

  • Rate of Complication

    1 year

Study Arms (2)

High power ablation

EXPERIMENTAL

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

Conventional ablation

ACTIVE COMPARATOR

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

Procedure: Catheter Ablation

Interventions

Catheter AblationPROCEDURE

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

Conventional ablationHigh power ablation

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National university Hostpital

Seoul, Jongno-gu, 03080, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 34621423DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Euekeun Choi, M.D. Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2020

First Posted

May 7, 2020

Study Start

October 30, 2018

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

May 7, 2020

Record last verified: 2019-11

Locations

KR(1)