search
Back to results

Efficacy of High Density Voltage and Fractionation Map Guided Ablation in Patients With Atrial Fibrillation (INVENTION)

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AF ablation
Sponsored by
Keimyung University Dongsan Medical Center
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:

  • 1. Age over 20 years old and under 80 years old 2. Patients with non-valvular atrial fibrillation 3. Patients having AF even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks 4. Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them 5. Patients who are available of follow-up at least for more than three months after catheter ablation

Exclusion Criteria:

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

Sites / Locations

  • Keimyung University Dongsan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High density voltage and fractionation map guided group

Circumferential PV isolation

Arm Description

Complex fractionated atrial electrogram (CFAE), voltage and fractionation map will be performed with a multielectrode mapping catheter. The mapping should be performed in AF. First, low-voltage zone is defined as an area with bipolar peak-to-peak voltage amplitudes < 0.5mV. A voltage-map guided segmental PV isolation is performed. Radiofrequency energy is applied in the antral regions of the PVs. High voltage zone over 0.5mV in the antral region is targeted. IF PV isolation in not achieved by voltage-guided segmental ablation, additional Lasso catheter guided segmental antral ablation is performed. Radiofrequency energy is delivered at target sites for 15-30 sec guided by contact force, lesion size index (LSI) and local electrogram elimination. If the patient is still in AF after PV isolation, additional fractionation map guided ablation is performed. The fractionation area within low voltage area (<0.5mV) should be targeted.

A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential PV isolation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acute AF termination rate during the procedure
Acute AF termination rate during the procedure
Complication rate
Compare complication rate between two groups
Total procedure time, ablation time, fluoroscopy time
Total procedure time, ablation time, fluoroscopy time between two groups

Full Information

First Posted
June 14, 2019
Last Updated
August 16, 2019
Sponsor
Keimyung University Dongsan Medical Center
Collaborators
Abbott
search

1. Study Identification

Unique Protocol Identification Number
NCT03989726
Brief Title
Efficacy of High Density Voltage and Fractionation Map Guided Ablation in Patients With Atrial Fibrillation
Acronym
INVENTION
Official Title
Efficacy of High Density Voltage and Fractionation Map Guided Ablation Compared to Anatomy-based Circumferential Pulmonary Vein Isolation in Patients With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keimyung University Dongsan Medical Center
Collaborators
Abbott

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of high density voltage and fractionation map guided ablation compared to anatomy-based circumferential pulmonary vein Isolation in patients with atrial fibrillation
Detailed Description
In this study, a test group includes those who undergoing atrial fibrillation(AF) ablation guided by high density voltage and fractionation map. A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential pulmonary vein (PV) isolation.

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
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High density voltage and fractionation map guided group
Arm Type
Experimental
Arm Description
Complex fractionated atrial electrogram (CFAE), voltage and fractionation map will be performed with a multielectrode mapping catheter. The mapping should be performed in AF. First, low-voltage zone is defined as an area with bipolar peak-to-peak voltage amplitudes < 0.5mV. A voltage-map guided segmental PV isolation is performed. Radiofrequency energy is applied in the antral regions of the PVs. High voltage zone over 0.5mV in the antral region is targeted. IF PV isolation in not achieved by voltage-guided segmental ablation, additional Lasso catheter guided segmental antral ablation is performed. Radiofrequency energy is delivered at target sites for 15-30 sec guided by contact force, lesion size index (LSI) and local electrogram elimination. If the patient is still in AF after PV isolation, additional fractionation map guided ablation is performed. The fractionation area within low voltage area (<0.5mV) should be targeted.
Arm Title
Circumferential PV isolation
Arm Type
Active Comparator
Arm Description
A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential PV isolation.
Intervention Type
Procedure
Intervention Name(s)
AF ablation
Intervention Description
AF ablation includes pulmonary vein isolation and/or voltage and fractionation guided ablation
Primary Outcome Measure Information:
Title
Free from atrial arrhythmia at 12 months
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Acute AF termination rate during the procedure
Description
Acute AF termination rate during the procedure
Time Frame
During the procedure
Title
Complication rate
Description
Compare complication rate between two groups
Time Frame
12 months
Title
Total procedure time, ablation time, fluoroscopy time
Description
Total procedure time, ablation time, fluoroscopy time between two groups
Time Frame
12 months

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: 1. Age over 20 years old and under 80 years old 2. Patients with non-valvular atrial fibrillation 3. Patients having AF even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks 4. Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them 5. Patients who are available of follow-up at least for more than three months after catheter ablation Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyoung-Seob Park, MD
Phone
+82-53-258-7725
Email
drparkgyver@gmail.com
Facility Information:
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
ZIP/Postal Code
42602
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyoung-Seob Park, MD
Phone
82532507473
Email
drparkgyver@gmail.com
First Name & Middle Initial & Last Name & Degree
Hyoung-Seob Park, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of High Density Voltage and Fractionation Map Guided Ablation in Patients With Atrial Fibrillation

We'll reach out to this number within 24 hrs