NCT02176616

Brief Summary

1\. Purpose of the study 1\) To compare clinical outcome, procedure time, complication rate of patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation between ablation with conventional pulmonary vein isolation and ablation with conventional pulmonary vein isolation with conventional linear ablation. 2\. Scientific evidence of the study

  • compare conventional pulmonary vein isolation with additional liner ablation, both strategies are conventional ablation strategies being performed world-wide.

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
120

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable atrial-fibrillation

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

June 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

9.7 years

First QC Date

June 23, 2014

Last Update Submit

March 27, 2019

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation

    lifelong, checked per every outpatient clinic visit

    1 year

Study Arms (2)

linear ablation

ACTIVE COMPARATOR

The group of positive control is the operation to add in conventional liner ablation to conventional pulmonary vein isolation with in patients based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation

Procedure: linear ablation

pulmonary vein isolation

EXPERIMENTAL

The group of negative is the operation to patients with only pulmonary vein isolation based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation

Procedure: pulmonary vein isolation

Interventions

linear ablationPROCEDURE

The group of positive control is the operation to add in conventional liner ablation to conventional pulmonary vein isolation with in patients based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation

linear ablation
pulmonary vein isolationPROCEDURE

The group of negative is the operation to patients with only pulmonary vein isolation based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation

pulmonary vein isolation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation

You may not qualify if:

  • permanent AF refractory to electrical cardioversion
  • AF with valvular disease ≥ grade 2
  • Patients with left atrial diameter greater than 60mm
  • patients with age less than 19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

Related Publications (2)

  • Pak HN, Park J, Park JW, Yang SY, Yu HT, Kim TH, Uhm JS, Choi JI, Joung B, Lee MH, Kim YH, Shim J. Electrical Posterior Box Isolation in Persistent Atrial Fibrillation Changed to Paroxysmal Atrial Fibrillation: A Multicenter, Prospective, Randomized Study. Circ Arrhythm Electrophysiol. 2020 Sep;13(9):e008531. doi: 10.1161/CIRCEP.120.008531. Epub 2020 Jul 28.

    PMID: 32755396DERIVED

  • Yu HT, Shim J, Park J, Kim IS, Kim TH, Uhm JS, Joung B, Lee MH, Kim YH, Pak HN. Pulmonary Vein Isolation Alone Versus Additional Linear Ablation in Patients With Persistent Atrial Fibrillation Converted to Paroxysmal Type With Antiarrhythmic Drug Therapy: A Multicenter, Prospective, Randomized Study. Circ Arrhythm Electrophysiol. 2017 Jun;10(6):e004915. doi: 10.1161/CIRCEP.116.004915.

    PMID: 28611206DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Hui-Nam Pak, MD

CONTACT

82-2-2228-8459hnpak@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2014

First Posted

June 27, 2014

Study Start

June 1, 2014

Primary Completion

February 1, 2024

Study Completion

June 1, 2024

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations

KR(1)