NCT02364401

Brief Summary

The purpose of this study is to compare the efficacy of catheter ablation for atrial fibrillation between contact force-guided and impedance-guided annotation using automated annotation system (Visitag™). Patients who receive atrial fibrillation ablation are randomly assigned in the same number to two groups with impedance guided ablation and contact force guided ablation using contact force sensing catheter (THERMOCOOL® SMARTTOUCH™ catheter, Biosense Webster, Inc., Diamond Bar, CA).

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 Feb 2015

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

January 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2016

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

January 30, 2015

Last Update Submit

August 16, 2017

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationCatheter ablation

Outcome Measures

Primary Outcomes (1)

  • Acute success rate of pulmonary vein isolation obtained after initial circumferential ablation line around pulmonary veins

    Acute success is defined as confirmation of entrance block in all pulmonary veins

    6 hours

Secondary Outcomes (6)

  • Recurrence of any atrial arrhythmias (atrial fibrillation or atrial tachycardia)

    12 months

  • Procedure time

    6 hours

  • Ablation time

    6 hours

  • Average contact force of each ablation lesion

    6 hours

  • Impedance drop of each ablation lesion

    6 hours

  • +1 more secondary outcomes

Study Arms (2)

Impedance Guided Ablation Group

EXPERIMENTAL

Impedance guided ablation group performs pulmonary vein(PV) isolation guided by annotation criteria with minimum time of 10 seconds, maximum range of 2 mm, and minimum impedance decrease over 5 Ohms instead of CF parameters. In the impedance guided group, operators are blinded to contact force data during PV isolation.

Device: Ablation

Contact Forced Guided Ablation Group

ACTIVE COMPARATOR

Contact force(CF) guided ablation group performs pulmonary vein (PV) isolation guided by automated annotation criteria with minimum time of 10 seconds, maximum range of 2mm, CF over time of 50% and minimum CF of 10 g.

Device: Ablation

Interventions

AblationDEVICE

Catheter ablation for atrial fibrillation

Also known as: THERMOCOOL® SMARTTOUCH™ catheter
Contact Forced Guided Ablation GroupImpedance Guided Ablation Group

Eligibility Criteria

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

You may qualify if:

  • 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 with tachycardia-bradycardia syndrome associated with atrial fibrillation.
  • 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 5.5cm
  • 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
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 18, 2015

Study Start

February 1, 2015

Primary Completion

November 15, 2016

Study Completion

December 15, 2016

Last Updated

August 21, 2017

Record last verified: 2016-08

Locations

KR(1)