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Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation

Primary Purpose

Atrial Fibrillation New Onset, Atrial Fibrillation Paroxysmal

Status

Terminated

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Amiodarone, diltiazem or esmolol

About this trial

This is an interventional treatment trial for Atrial Fibrillation New Onset

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Rate control strategy group

Rhythm control strategy group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of sinus conversion

Rate of sinus conversion within 48 hours

Secondary Outcome Measures

Time to first sinus conversion

Recurrence of atrial fibrillation

Recurrence of atrial fibrillation during the same admission period

Full Information

NCT ID

NCT05950971

First Posted

December 5, 2021

Last Updated

July 10, 2023

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05950971

Brief Title

Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Terminated

Why Stopped

Study enrollment too slow, 1 over 6 months

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

January 21, 2022 (Actual)

Study Completion Date

January 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation New Onset, Atrial Fibrillation Paroxysmal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Single blinded randomized controlled trial

Masking

Participant

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rate control strategy group

Arm Type

Experimental

Arm Description

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

Arm Title

Rhythm control strategy group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Amiodarone, diltiazem or esmolol

Other Intervention Name(s)

herben

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of sinus conversion

Description

Rate of sinus conversion within 48 hours

Time Frame

within 48 hrs

Secondary Outcome Measure Information:

Title

Time to first sinus conversion

Description

Time to first sinus conversion

Time Frame

during the same admission period

Title

Recurrence of atrial fibrillation

Description

Recurrence of atrial fibrillation during the same admission period

Time Frame

during the same admission period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hogeol Ryu

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Rhythm Control Versus Rate Control for New Onset Atrial Fibrillation

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