Chemical vs Electrical Cardioversion for Emergency Department Patients With Acute Atrial Fibrillation
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Electrical-first (Drug); Chemical-first (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s): Frank Scheuermeyer, MD, Principal Investigator, Affiliation: St. Paul's Hospital
Summary
Atrial fibrillation (AF) is the most common type of irregular heartbeat in emergency
department (ED) patients. If the irregular heartbeat has been present for less than 48
hours, there is a chance that emergency treatment can convert the heartbeat into normal
rhythm.
There are currently two options for accomplishing this; both are widely and safely used in
EDs. Each has its advantages and disadvantages. This study will compare the two methods. (1)
Patients are given an intravenous medication called procainamide; this converts patients
into a normal heart rhythm around 50% of the time. (2) Patients are sedated (put to sleep
with a general anesthetic) for about ten minutes, while an electrical current is conducted
across the chest; this converts patients into a normal heart rhythm around 90% of the time.
Procainamide can cause low blood pressure in about 10% of patients; this is usually
corrected by administering intravenous fluids. Sedation can cause low blood pressure in
about 10% of patients, and breathing trouble in about 10% of patients; this is usually
corrected by administering intravenous fluids, and administering more oxygen, respectively.
In thousands of patients studied around the world, there does not appear to have been a
reported stroke or death as a result of these procedures.
A physician will choose one method, but if it fails, will move to the next method. There are
thus two options. (1) Chemical conversion, followed by electrical conversion; and (2)
Electrical cardioversion, followed by chemical cardioversion. These options both have a 90%+
chance of converting AF into a normal heart rhythm. However, the investigators believe that
an electrical-chemical sequence will be faster than a chemical-electrical sequence, while
both will be equally safe.
If patients agree to take part in the study, they will be randomized to one of the two
options. They will have their breathing, oxygen levels, blood pressure, and heartbeat
monitored for their entire ED stay.
The investigators plan to enrol 86 patients at five hospitals over the course of about one
year. The primary outcome of ED length-of-stay, as well as secondary outcomes, such as
conversion to normal rhythm, and adverse events (such as trouble breathing or low blood
pressure) will be documented. In addition, an investigator will contact you at three and
thirty days after your visit to make sure that there are no problems. Importantly, although
the principal and site investigators will be aware of the primary outcome, attending
emergency physicians who actually provide patient care will NOT be aware of the primary
outcome--otherwise this could bias patient management.
When the study is finished, the results will be given to the writing committee merely as the
"A" and "B" arms, and not specified as either the "chemical-first" or "electrical-first"
arms. The writing committee will compose two manuscripts, (1) assuming that "A" is the
"chemical-first" arm and "B" the "electrical-first" arm, and (2) assuming that "A" is the
"electrical-first"arm, and "B" the "chemical-first" arm. After both manuscripts have been
approved by all authors, the blinding will be removed and only the correct manuscript
submitted for publication.
Clinical Details
Official title: A Randomized Crossover Trial to Evaluate Electrical Versus Chemical Cardioversion in Patients With Acute Atrial Fibrillation
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Length-of-stay
Secondary outcome: Adverse events
Eligibility
Minimum age: 19 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Must have an abnormal heart rhythm diagnosed as AF for less than 48 hours.
- Be eligible for cardioversion (in the judgment of the study doctor).
- Are on the appropriate blood thinner medications.
- Have systolic blood pressure (SBP) above 90 mmHg and less than 160 mmHg and diastolic
blood pressure (DBP) less than 95 mmHg at screening and baseline.
- Are adequately hydrated (in the judgment of the study doctor) and have a normal
saline intravenous established and it is working properly.
- Must have a body weight between 45 and 136 kg inclusive (99 and 300 lbs).
- Be able and willing to give informed consent.
Exclusion Criteria:
- Pregnant or nursing a child
- Are diagnosed with any other serious lung, liver, metabolic, kidney,
gastrointestinal, central nervous system, or psychiatric disease, infection, having a
fever, end stage disease states, or any other diseases that could interfere with the
conduct of this study. Your study doctor will confirm this with you.
- Have an infection or fever
- Are allergic to procainamide (the chemical conversion agent) or propofol (the
sedative agent)
- Are participating in another drug study or have received an experimental drug within
30 days prior to screening in this study
- Are not currently living in the Vancouver Coastal Health Region
- Are unable or unwilling to be contacted at 30 days by one of the study doctors or
study staff to determine 30-day outcomes
- Are unwilling to sign the informed consent form
- Are unable to speak English
Locations and Contacts
St Paul's Hospital, Vancouver, British Columbia V6Z 1Y6, Canada
Additional Information
Starting date: November 2013
Last updated: June 10, 2015
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