Endocardial catheter ablation versus thoracoscopic ablation in de novo persistent atrial fibrillation patients with enlarged left atrium : A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009360

Enrollment

194

Registered

2024-04-22

Start date

2024-04-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

None listed

Interventions

Procedure/Surgery : Thoracic resection: It is performed according to standard procedures, and pulmonary vein resection, roof, internal line, ligament of Marshall defect, and left atrial resection must

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 19 years of age or older 2. Patients with persistent atrial fibrillation who have failed antiarrhythmic treatment or are unable to maintain antiarrhythmic drugs 3. European Heart Rhythm Association score for AF(EHRA) = 2 4. A person who is deemed appropriate to treat atrial fibrillation rhythm control through percutaneous catheter resection or thoracoscopic resection (prescribed by the investigator as medical judgment) 5. Patients with left atrial hypertrophy (LA diameter = 50 mm or LAVI = 45 ml/?)

Exclusion criteria

Exclusion criteria: 1. Patients who have undergone percutaneous catheter resection or thoracoscopic resection for past atrial fibrillation 2. a patient who has had past chest or heart surgery 3. If there is an absolute contraindication to anticoagulant therapy 4. A person whose life expectancy is less than one year due to a non-heart disease or who is expected to be less compliant with treatment (as determined by the investigator by medical judgment) 5. a patient who refused to participate in the study

Design outcomes

Primary

Measure	Time frame
First recurrence of atrial tachyarrhythmia	—

Secondary

Measure	Time frame
First recurrence of atrial fibrillation, First recurrence of atrial flutter, First recurrence of atrial tachycardia, All-cause and cardiac death, Stroke, Hospitalization for heart failure, Bleeding, % Burden of atrial tachyarrhythmia or atrial fibrillation, Detection rate of atrial tachyarrhythmia in 14-day patch holter and 24-hour holter at 3-month, 6-month, and 12-month after the index procedure, Echocardiographic parameters, NT proBNP, procedure related outcomes, Adverse Event, Patients' quality of life	—

Measure

Time frame

First recurrence of atrial fibrillation, First recurrence of atrial flutter, First recurrence of atrial tachycardia, All-cause and cardiac death, Stroke, Hospitalization for heart failure, Bleeding, % Burden of atrial tachyarrhythmia or atrial fibrillation, Detection rate of atrial tachyarrhythmia in 14-day patch holter and 24-hour holter at 3-month, 6-month, and 12-month after the index procedure, Echocardiographic parameters, NT proBNP, procedure related outcomes, Adverse Event, Patients' quality of life

—

Countries

Korea, Republic of

Contacts

Public ContactYoung Keun On

Samsung Medical Center

yk.on@samsung.com+82-2-3410-2986

Outcome results