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Evaluation of Proper Radiofrequency Catheter Ablation Strategy for the Patients Who Were Changed to Paroxysmal Atrial Fibrillation From Persistent Atrial Fibrillation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02176616
Enrollment
120
Registered
2014-06-27
Start date
2014-06-30
Completion date
2024-06-30
Last updated
2019-03-28

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

Conditions

Atrial Fibrillation

Brief summary

1\. Purpose of the study 1\) To compare clinical outcome, procedure time, complication rate of patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation between ablation with conventional pulmonary vein isolation and ablation with conventional pulmonary vein isolation with conventional linear 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 patients who were changed to paroxysmal atrial fibrillation from 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 pulmonary vein isolation with additional conventional linear 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 patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation * compare conventional pulmonary vein isolation with additional liner ablation, both strategies are conventional ablation strategies being performed world-wide.

Interventions

The group of positive control is the operation to add in conventional liner ablation to conventional pulmonary vein isolation with in patients based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation

PROCEDUREpulmonary vein isolation

The group of negative is the operation to patients with only pulmonary vein isolation based on patients who were changed to paroxysmal atrial fibrillation from 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

Contacts

Primary ContactHui-Nam Pak, MD
hnpak@yuhs.ac82-2-2228-8459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026