Clinical trial NCT04121767: Safety and Efficacy of Edoxaban in Thoracoscopic Ablation
Official title: Safety and Efficacy of Edoxaban Versus Warfarin in Patients Undergoing a Thoracoscopic Ablation for Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Anticoagulants and Bleeding Disorders
Keywords: atrial fibrillation
thoracoscopic ablation
anticoagulation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the safety and efficacy of edoxaban and warfarin for prevention of stroke during a 6-month follow up after total thoracoscopic ablation.

Detailed description: In Korea, 5% of patients older than 65 years and 10% of patients older than 80 have a history of atrial fibrillation (AF), which is often associated with sudden death and stroke. Medication and percutaneous radiofrequency catheter ablation are commonly used treatment modalities. Pharmacotherapy is primarily symptomatic treatment; moreover, the effect of conversion to a normal rhythm is minimal, and mainly aimed at stabilizing heart rate. Catheter ablation is associated with a high incidence of recurrence in chronic AF, and it is difficult to treat left atrial appendage, thereby preventing discontinuation of anticoagulation therapy post procedure. Thoracoscopic ablation is known to be a less invasive and more effective modality to treat patients with chronic atrial fibrillation. However, anticoagulation therapy is mandatory in the early postoperative period due to intracardiac thromboembolism associated with atrial stunning despite conversion to a sinus rhythm and resection of the left atrial appendage. Further investigation would be required to assess the efficacy and safety of novel oral anticoagulants such as edoxaban compared to that of warfarin for stroke prevention during the early postoperative period (6 months) after a thoracoscopic procedure. The need to maintain a constant level of blood coagulation and the potential development of complications such as hemorrhages are drawbacks associated with the use of warfarin. While novel oral anticoagulants such as edoxaban do have a role in atrial fibrillation, data regarding their effectiveness and incidence of complications after arrhythmia surgery do not exist. In this study, we will compare warfarin and edoxaban with respect to safety and efficacy, after they are used for 6 months following thoracoscopic ablation in patients with chronic atrial fibrillation

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 years or older (not exceed 80 years old).
2. Elective thoracoscopic ablation.
3. Presence of atrial fibrillation (paroxysmal, persistent, long-standing persistent).

Exclusion Criteria:

1. Chronic obstructive pulmonary disease (COPD).
2. History of pulmonary tuberculosis.
3. Other cardiac comorbidities including valvular disease, coronary artery disease.
4. Congenital heart anomalies except for atrial septal defect.
5. Known, clinically important anemia or thrombocytopenia.
6. Pregnancy or lactation.
7. Malignancy.
8. Intracardiac mass or thrombus
9. Life expectancy less than 1 year.

Primary outcomes:
measure: Postoperative stroke
timeFrame: 6 months
Secondary outcomes:
measure: Postoperative bleeding
timeFrame: 6 months
measure: Postoperative pericarditis
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Dong Seop Jeong, PhD
role: PRINCIPAL_INVESTIGATOR
References: