AF Ablation Based on High Density Voltage Mapping and CFAE

Atrial Fibrillation Clinical Trial

Official title:

Ablation of Persistent Atrial Fibrillation Based on High Density Voltage Mapping and Complex Fractionated Atrial Electrogram

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03046043
• Other study ID #: DSMCEP_PHS_002
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: December 23, 2019

Study information

• Verified date: March 2019
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Fifty patients with persistent atrial fibrillation will be randomized a 1:1 ratio to each group. A test group includes those who undergoing ablation targeting low voltage areas which contains complex fractionated trial electrogram in addition to pulmonary vein isolation and a control group includes who undergoing pulmonary vein isolation only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 23, 2019
• Est. primary completion date: November 30, 2019
• 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 atrial fibrillation 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:
• pulmonary vein isolation
pulmonary vein isolation is conducted on the junction between the left atrium and pulmonary vein
• Low-Voltage & CFAE guided ablation
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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center	Biosense Webster, Inc.

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	Complication rate	Compare complication rate between two groups	12 months
Secondary	Total procedure time, ablation time and fluoroscopy time	Compare total procedure time, ablation time and fluoroscopy time between two groups	12 months