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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02175043
Enrollment
40
Registered
2014-06-26
Start date
2014-06-03
Completion date
2017-02-28
Last updated
2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, catheter ablation, recurrence

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

Interventions

PROCEDUREatrial electrogram and liner ablation

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

1. patients who do not agree with study inclusion 2. permanent AF refractory to electrical cardioversion 3. AF with valvular disease ≥ grade 2 4. Patients with left atrial diameter greater than 60mm 5. patients with age less than 19

Design outcomes

Primary

MeasureTime frameDescription
number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation1 yearlifelong, checked per every outpatient clinic visit

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026