Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation

Not Applicable

Terminated

• Conditions: Atrial Fibrillation New Onset; Atrial Fibrillation Paroxysmal
• Interventions: Drug: Amiodarone, diltiazem or esmolol

• Registration Number: NCT05950971
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Adult patients who are diagnosed new onset atrial fibrillation with rapid ventricular response within 7 days after non-cardiac non-thoracic surgery are enrolled.

Detailed Description

After randomization, they are allocated to rhythm control strategy group or rate control strategy group. In rhythm control strategy group, patients are given amiodarone primarily for the purpose of sinus conversion of cardiac rhythm. In rate control strategy group, patients are given diltiazem or esmolol for the purpose of rate control. the rate of sinus conversion within 48 hours after treatment are compared.

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-12-05
• Primary Completion: 2022-01-21
• Study Completion: 2022-01-21
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-10
• Last Update Submitted: 2023-07-10
• Study First Posted: 2023-07-18
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Older than 18 years
• Newly diagnosed atrial fibrillation or flutter
• Patients with atrial fibrillation or flutter that occurred within 7 days after non-cardiac non-thoracic surgery
• Atrial fibrillation or flutter with rapid ventricular response(HR ≥110/min)
• Patients without hemodynamic instability (MBP≥65mmHg with norepinephrine continuous infusion less than 5mcg/min or without vasopressor support)

Exclusion Criteria

• Atrial fibrillation or flutter prolonged more than 48 hours without anticoagulation
• Patients who have decreased cardiac function or heart failure (EF <40%)
• Patients who have cardiac conduction disorder, QT prolongation(QTc ≥500ms)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rate control strategy group	Amiodarone, diltiazem or esmolol	Patients are given diltiazem or esmolol to control heart rate less than 110/min.
Rhythm control strategy group	Amiodarone, diltiazem or esmolol	Patients are given amiodarone for conversion of cardiac rhythm to sinus rhythm.

Primary Outcome Measures

Name	Time	Method
Rate of sinus conversion	within 48 hrs	Rate of sinus conversion within 48 hours

Secondary Outcome Measures

Name	Time	Method
Time to first sinus conversion	during the same admission period	Time to first sinus conversion
Recurrence of atrial fibrillation	during the same admission period	Recurrence of atrial fibrillation during the same admission period

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of