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Rate Control Agent

Rhythm-control strategy for Atrial Fibrillation (RAFTS Trial)

Phase 4
Waitlist Available
Led By Hollis R O'Neal, MD
Research Sponsored by Our Lady of the Lake Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

RAFTS Trial Summary

This trial is testing whether it's better to control the heart's rhythm or rate in septic shock patients with new onset atrial fibrillation. Outcomes will be measured.

Eligible Conditions
  • Atrial Fibrillation
  • Sepsis
  • Respiratory Failure

RAFTS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ICU Length of Stay (LOS)
Vasopressor days
Ventilation-free days

RAFTS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Rhythm-control strategyExperimental Treatment3 Interventions
The patient will receive 1) amiodarone 150mg bolus over ten minutes followed by intravenous (IV) 1mg/min for 6 hours and then 0.5mg/min for 18hours, and 2) direct current cardioversion (DCC) at the completion of initial 6 hour IV bolus or within 24 hours of new onset of atrial fibrillation. Patient will be placed on by mouth amiodarone 400mg three times daily for seven days, then 400mg twice daily for seven days, then 400mg once daily for seven days, then 200mg daily until stop date which will be by provider discretion after discharge from ICU. If the patient does not convert to a normal sinus rhythm with routine DCC then they will remain in the rhythm-control strategy to receive amiodarone as directed. Amiodarone may be extended at discretion of provider for 30 days with discontinuation if adverse effects. If no contraindications, anticoagulation will be recommended prior to DCC with enoxaparin 1mg/kg every 12 hours.
Group II: Rate-control strategyActive Control1 Intervention
At treating physician's discretion, one of the following, or a combination of the following, will be administered to the patient: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin. The target heart rate is less than 120 beats per minute (bpm) or maintained hemodynamics. Patients in the rate-control arm who are hypotensive after new onset atrial fibrillation can undergo DCC at the provider's discretion and crossover into the rhythm-control arm.

Find a Location

Who is running the clinical trial?

Our Lady of the Lake HospitalLead Sponsor
12 Previous Clinical Trials
799 Total Patients Enrolled
Our Lady of the Lake Regional Medical CenterLead Sponsor
5 Previous Clinical Trials
429 Total Patients Enrolled
Hollis R O'Neal, MDPrincipal InvestigatorLouisiana State University Health Sciences Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Rapid Atrial Fibrillation Treatment Strategy
Hollis O Neal 2019. "Rapid Atrial Fibrillation Treatment Strategy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04092621.
~7 spots leftby Apr 2025
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