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

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03989726
• Other study ID #: DSMCEP_PHS_003
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: June 2019
• Source: Keimyung University Dongsan Medical Center
• Contact: Hyoung-Seob Park, MD
• Phone: +82-53-258-7725
• Email: drparkgyver[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• AF ablation
AF ablation includes pulmonary vein isolation and/or voltage and fractionation guided ablation

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu

Sponsors (2)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center	Abbott

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acute AF termination rate during the procedure	Acute AF termination rate during the procedure	During the procedure
Secondary	Complication rate	Compare complication rate between two groups	12 months
Secondary	Total procedure time, ablation time, fluoroscopy time	Total procedure time, ablation time, fluoroscopy time between two groups	12 months