Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation

Atrial Fibrillation New Onset Clinical Trial

Official title:

Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation After Non-cardiac Non-thoracic Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05950971
• Other study ID #: Postoperative NOAF
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: January 21, 2022

Study information

• Verified date: July 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 21, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset
• Atrial Fibrillation Paroxysmal

Intervention

Drug:
• Amiodarone, diltiazem or esmolol
Intravenous continuous infusion after loading or bolus dose of amiodarone, diltiazem or esmolol.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of sinus conversion	Rate of sinus conversion within 48 hours	within 48 hrs
Secondary	Time to first sinus conversion	Time to first sinus conversion	during the same admission period
Secondary	Recurrence of atrial fibrillation	Recurrence of atrial fibrillation during the same admission period	during the same admission period