NCT03046043

Brief Summary

The purpose of this study is to evaluate the efficacy of additional ablation targeting complex fractionated atrial electrogram area within low voltage zone identified by high resolution mapping in patients with persistent atrial fibrillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed
Last Updated

February 21, 2020

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

February 3, 2017

Last Update Submit

February 20, 2020

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Free from atrial arrhythmia at 12 months

    Freedom from any atrial arrhythmia lasting longer than 30 seconds during 1 year follow-up after single ablation with or without the use of antiarrhythmic medications with the exclusion of the 3-month blanking period.

    12 months

Secondary Outcomes (2)

  • Complication rate

    12 months

  • Total procedure time, ablation time and fluoroscopy time

    12 months

Study Arms (2)

Low-Voltage & CFAE guided ablation

EXPERIMENTAL

* Pulmonary isolation will be performed * Complex fractionated atrial electrogram(CFAE) and voltage mapping will be performed if atrial fibrillation the patient is still in atrial fibrillation after pulmonary vein isolation * CFAE and voltage mapping will be performed simultaneously using small electrode Pentaray® Catheter with CARTO®3 MEM version or CARTO®3 CONFIDENSE™ * Automatic characterization of CFAE signals will be performed with an CARTO® CFAE software module. * CFAE areas within low voltage zone in the left atrium should be targeted first. If atrial fibrillation persist after left atrial ablation, target areas in the right atrium should be mapped and ablated. (Low-Voltage \& CFAE guided ablation)

Procedure: pulmonary vein isolationProcedure: Low-Voltage & CFAE guided ablation

PV Isolation Only

ACTIVE COMPARATOR

* Pulmonary vein isolation will be performed. * Electrical cardioversion to sinus rhythm will be performed if the patient is still in atrial fibrillation after pulmonary vein isolation.

Procedure: pulmonary vein isolation

Interventions

pulmonary vein isolationPROCEDURE

pulmonary vein isolation is conducted on the junction between the left atrium and pulmonary vein

Low-Voltage & CFAE guided ablationPV Isolation Only
Low-Voltage & CFAE guided ablationPROCEDURE

In CFAE guided ablation,. Within low voltage zone, CFAE areas defined by shortest SCI and high ICL are identified.-Areas with the shortest SCI and high ICL within low voltage areas should be targeted first, followed by longer SCI regions (up to 120ms). Radiofrequency energy is delivered at target sites for 30-60 sec until the local electrogram is completely eliminated.

Low-Voltage & CFAE guided ablation

Eligibility Criteria

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

You may qualify if:

  • Age over 20 years old and under 80 years old
  • Patients with non-valvular atrial fibrillation
  • Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
  • Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them
  • Patients who are available of follow-up at least for more than three months after catheter ablation

You may not qualify if:

  • Patients unsuitable for catheter ablation because the size of left atrium is over 6.0 cm
  • Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.
  • Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation
  • Patients in the subject group vulnerable to clinical study
  • Patients who had undergone a prior catheter ablation for atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hyoung-Seob Park, MD

    Keimyung University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 3, 2017

First Posted

February 8, 2017

Study Start

October 1, 2017

Primary Completion

November 30, 2019

Study Completion

December 23, 2019

Last Updated

February 21, 2020

Record last verified: 2019-03

Locations

KR(1)