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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05950971
Other study ID # Postoperative NOAF
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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