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

• Sponsor: Keimyung University Dongsan Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03989726
• Collaborator: Abbott (Industry)
• Enrollment: 160
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 7

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: AF ablation	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 1, 2019
• Anticipated Primary Completion Date: Feb 28, 2021
• Anticipated Study Completion Date: May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High density voltage and fractionation map guided group 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.	Procedure: AF ablation; AF ablation includes pulmonary vein isolation and/or voltage and fractionation guided ablation
Active Comparator: Circumferential PV isolation 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.	Procedure: AF ablation; AF ablation includes pulmonary vein isolation and/or voltage and fractionation guided ablation

Outcome Measures

Primary Outcome Measures

1. Free from atrial arrhythmia at 12 months [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

1. Acute AF termination rate during the procedure [During the procedure]

   Acute AF termination rate during the procedure

2. Complication rate [12 months]

   Compare complication rate between two groups

3. Total procedure time, ablation time, fluoroscopy time [12 months]

   Total procedure time, ablation time, fluoroscopy time between two groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keimyung University Dongsan Hospital	Daegu		Korea, Republic of	42602

Sponsors and Collaborators

• Keimyung University Dongsan Medical Center
• Abbott

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Keimyung University Dongsan Medical Center
• ClinicalTrials.gov Identifier: NCT03989726
• Other Study ID Numbers: DSMCEP_PHS_003
• First Posted: Jun 18, 2019
• Last Update Posted: Aug 20, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Aug 20, 2019