Skip to content

Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05950971
Enrollment
1
Registered
2023-07-18
Start date
2021-07-01
Completion date
2022-01-21
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation New Onset, Atrial Fibrillation Paroxysmal

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.

Interventions

DRUGAmiodarone, diltiazem or esmolol

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Single blinded randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Rate of sinus conversionwithin 48 hrsRate of sinus conversion within 48 hours

Secondary

MeasureTime frameDescription
Time to first sinus conversionduring the same admission periodTime to first sinus conversion
Recurrence of atrial fibrillationduring the same admission periodRecurrence of atrial fibrillation during the same admission period

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026