Clinical Benefits of Additional Complex Fractionated Atrial Electrogram Targeted Catheter Ablation for Longstanding Persistent Atrial Fibrillation

NCT02175043 | Completed DMC

• 1 other identifier: 4-2014-0282
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

1\. Purpose of the study 1\) To compare clinical outcome, procedure time, complication rate of persistent atrial fibrillation patients between conventional additional linear ablation and additional complex fractionated atrial electrogram targeted catheter ablation. 2\. Scientific evidence of the study

1. 1.In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality.
2. 2.drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed.
3. 3.catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy.
4. 4.However, there are no consensus for proper ablation strategy in longstanding persistent atrial fibrillation.
5. 5.additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial.
6. 6.Therefore, we will compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation.
7. 7.Treatment of All patients with atrial fibrillation is performed according to the standard treatment guideline of atrial fibrillation.
8. 8.there is no additional blood sampling, imaging study, or any other invasive procedure according to the inclusion of the study.
9. 9.to evaluate superior ablation strategy in longstanding persistent atrial fibrillation
10. 10.compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation. both strategies are conventional ablation strategies being performed world-wide.
11. 11.compare complex fractionated atrial electrogram before and after linear ablation.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, catheter ablation, recurrence

Outcome Measures

Primary Outcomes (1)

• number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation

  lifelong, checked per every outpatient clinic visit

  1 year

Study Arms (2)

the operation to add in CFAE to conventional liner ablation

EXPERIMENTAL

The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients

Procedure: atrial electrogram and liner ablation

only doing conventional liner ablation

ACTIVE COMPARATOR

The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation

Procedure: atrial electrogram and liner ablation

Interventions

atrial electrogram and liner ablation PROCEDURE

1. The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients 2. The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation

only doing conventional liner ablation; the operation to add in CFAE to conventional liner ablation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation

You may not qualify if:

• permanent AF refractory to electrical cardioversion
• AF with valvular disease ≥ grade 2
• Patients with left atrial diameter greater than 60mm
• patients with age less than 19

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation; Recurrence

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 26, 2014
• Study Start: June 3, 2014
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

KR (1)