Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation

NCT ID: NCT05950971

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-01-21

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.

Conditions

Atrial Fibrillation New Onset; Atrial Fibrillation Paroxysmal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Rate control strategy group

Patients are given diltiazem or esmolol to control heart rate less than 110/min.

Group Type: EXPERIMENTAL

Amiodarone, diltiazem or esmolol

Intervention Type: DRUG

Intravenous continuous infusion after loading or bolus dose of amiodarone, diltiazem or esmolol.

Rhythm control strategy group

Patients are given amiodarone for conversion of cardiac rhythm to sinus rhythm.

Group Type: EXPERIMENTAL

Amiodarone, diltiazem or esmolol

Intervention Type: DRUG

Intravenous continuous infusion after loading or bolus dose of amiodarone, diltiazem or esmolol.

Interventions

Amiodarone, diltiazem or esmolol

Intravenous continuous infusion after loading or bolus dose of amiodarone, diltiazem or esmolol.

Intervention Type: DRUG

Other Intervention Names

herben

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ho Geol Ryu

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hogeol Ryu

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

Postoperative NOAF

Identifier Type: -

Identifier Source: org_study_id