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Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

NCT02132767 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 523

Last updated 2019-03-15

Study results available
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Summary

The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.

Conditions

  • Postoperative Atrial Fibrillation

Interventions

DRUG

Amiodarone

Amiodarone Initial Dose * Oral: 400 mg po TID for 3 days is recommended * For patients incapable of taking oral: 150 mg IV bolus over 10 min, then 1 mg/min over 6 hours followed by 0.5 mg/min over 18 hours Maintenance Dose * Oral: at least 200 mg/day to be continued until 60 days after randomization * If drug cannot be given orally or via NG tube: 0.5 mg/min administered through central line (e.g., PICC) until oral dosing is started

PROCEDURE

DC-cardioversion

DC-Cardioversion - frequency and duration determined by medical professional as medically needed

DRUG

Rate Control

Beta-blocker and/or Calcium channel blockers and/or Digoxin - Dose, frequency and duration determined by medical professional as medically needed

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Icahn School of Medicine at Mount Sinai

    lead OTHER

Principal Investigators

  • Richard Wiesel, MD · Cardiothoracic Surgical Trials Network

  • Patrick T O'Gara, MD · Cardiothoracic Surgical Trials Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02132767 on ClinicalTrials.gov