Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation

NCT05950971 — Not applicable, Terminated, 1 participants, Seoul National University Hospital

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

Registry	NCT05950971
Status	Terminated - Study enrollment too slow, 1 over 6 months
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	1 (Actual)
Sponsor	Seoul National University Hospital (Other)
Conditions	Atrial Fibrillation New Onset, Atrial Fibrillation Paroxysmal
Interventions	Amiodarone, diltiazem or esmolol (Drug)
Dates	start 2021-07-01, primary completion 2022-01-21, completion 2022-01-21, first posted 2023-07-18, last updated 2023-07-18
Locations	1 site in South Korea

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Rate control strategy group	Experimental	Drug: Amiodarone, diltiazem or esmolol	Patients are given diltiazem or esmolol to control heart rate less than 110/min.
Rhythm control strategy group	Experimental	Drug: Amiodarone, diltiazem or esmolol	Patients are given amiodarone for conversion of cardiac rhythm to sinus rhythm.

Amiodarone, diltiazem or esmolol (Drug), also known as herben: Intravenous continuous infusion after loading or bolus dose of amiodarone, diltiazem or esmolol.

+Outcome measures

Primary outcomes

Rate of sinus conversion [within 48 hrs]: Rate of sinus conversion within 48 hours

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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)

+Locations (1)

Facility	City	Country	Status
Seoul National University Hospital	Seoul	South Korea

+Investigators

Hogeol Ryu, Principal investigator, Seoul National University Hospital