Atrial FibrillationPhase 3NCT01994070
Chemical vs Electrical Cardioversion for Emergency Department Patients With Acute Atrial Fibrillation
A Phase 3 study testing Electrical-first and Chemical-first in people with Atrial Fibrillation, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Electrical-first and Chemical-first
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Apr 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Crossover Trial to Evaluate Electrical Versus Chemical Cardioversion in Patients With Acute Atrial Fibrillation
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.
Read more
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Electrical-first, Chemical-first
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical-firstDrug
Also called DC cardioversion
Patients will be placed on cardiopulmonary blood pressure monitoring, and sedated with propofol 0.5 - 1.0 mg / kg. Once a Ramsay Sedation Scale score of 5 or greater is reached, the physician will attempt synchronized electrical cardioversion with 100 J, 200 J, 200 J. If the patient converts to normal sinus rhythm by the third shock, the physician may discharge the patient. If atrial fibrillation is maintained, the patient will receive intravenous procainamide 17 mg / kg over 30 minutes. If the rhythm has changed from atrial fibrillation to normal sinus within one hour, the attending physician may discharge the patient, otherwise a cardiologist will be consulted.
Chemical-firstDrug
Also called procainamide
Patients will be placed on cardiopulmonary blood pressure monitoring, and will receive intravenous procainamide 17 mg / kg over 30 minutes. If the rhythm has changed from atrial fibrillation to normal sinus within one hour, the attending physician may discharge the patient. If the rhythm has not changed, then the patient will be continue to have cardiopulmonary monitoring, but also be attended by a respiratory therapist. The patient will be sedated with propofol 0.5 - 1.0 mg / kg. Once a Ramsay Sedation Scale score of 5 or greater is reached, the physician will attempt synchronized electrical cardioversion with 100 J, 200 J, 200 J. If the patient converts to normal sinus rhythm by the third shock, the physician may discharge the patient, otherwise a cardiologist will be consulted.
| Study group | Role | What they receive |
|---|---|---|
| Electrical-first | Active comparator | Patients in atrial fibrillation for less than 48 hours will be administered procedural sedation and analgesia and an electrical current applied across their chest (cardioversion) to attempt conversion to normal sinus rhythm. If this does not succeed, they will be given intravenous procainamide (chemical cardioversion). If procainamide is required, physicians will be informed as follows: "50% of patients convert to normal sinus rhythm within one hour and 90% of patients convert within two hours." Physicians can then proceed at their discretion. Receives: Drug: Electrical-first |
| Chemical-first | Active comparator | Patients in atrial fibrillation for less than 48 hours will be administered intravenous procainamide (chemical cardioversion) to attempt conversion to normal sinus rhythm. If procainamide is required, physicians will be informed as follows: "50% of patients convert to normal sinus rhythm within one hour and 90% of patients convert within two hours." Physicians can then proceed at their discretion. If this does not succeed, patients will be administered procedural sedation and analgesia and an electrical current applied across their chest (electrical cardioversion) to attempt conversion to normal sinus rhythm. Receives: Drug: Chemical-first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length-of-stay
Length of stay is defined as the time from patient randomization to discharge from the emergency department.
Measured: up to 12 hours
Secondary outcomes (1)
Adverse events
- Sentinel risk
- Oxygen desaturation > 60 seconds or < 75%
- Apnea > 60 seconds
- Shock
- Cardiac arrest
- Minor risk
- Oxygen desaturation < 60 seconds
- Apnea < 20 seconds
- Airway obstruction
- Failed sedation
- Allergic reaction, no anaphylaxis
- Bradycardia
- Tachycardia
- Hypotension
- Hypertension
- Ventricular arrhythmia
- Seizure
- Minimal risk
- Vomiting / retching
- Subclinical respiratory depression
- Muscle rigidity
- Hypersalivation
- Paradoxical response
- Recovery agitation
- Prolonged recovery
Note: All potential adverse events will be referred to a central safety committee. Members of this committee will be blinded to patient treatment group and blinded to 3- and 30-day outcomes. The central safety committee will determine whether an adverse event occurred and categorize the severity.
Measured: up to 12 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Scheuermeyer, MD, Principal investigator, St. Paul's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994070
- Sponsor's protocol ID
- H12-00408
- Status last verified
- Jun 2015
- First submitted
- 11 Nov 2013
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Trial to Evaluate Electrical Versus Chemical Cardioversion in Patients With Acute Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01994070
- Acronym / sponsor ID
- H12-00408
- Conditions
- Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical-first | Active comparator | Drug: Electrical-firstPatients in atrial fibrillation for less than 48 hours will be administered procedural sedation and analgesia and an electrical current applied across their chest (cardioversion) to attempt conversion to normal sinus rhythm. If this does not succeed, they will be given intravenous procainamide (chemical cardioversion). If procainamide is required, physicians will be informed as follows: "50% of patients convert to normal sinus rhythm within one hour and 90% of patients convert within two hours." Physicians can then proceed at their discretion. |
| Chemical-first | Active comparator | Drug: Chemical-firstPatients in atrial fibrillation for less than 48 hours will be administered intravenous procainamide (chemical cardioversion) to attempt conversion to normal sinus rhythm. If procainamide is required, physicians will be informed as follows: "50% of patients convert to normal sinus rhythm within one hour and 90% of patients convert within two hours." Physicians can then proceed at their discretion. If this does not succeed, patients will be administered procedural sedation and analgesia and an electrical current applied across their chest (electrical cardioversion) to attempt conversion to normal sinus rhythm. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical-firstAlso: DC cardioversionPatients will be placed on cardiopulmonary blood pressure monitoring, and sedated with propofol 0.5 - 1.0 mg / kg. Once a Ramsay Sedation Scale score of 5 or greater is reached, the physician will attempt synchronized electrical cardioversion with 100 J, 200 J, 200 J. If the patient converts to normal sinus rhythm by the third shock, the physician may discharge the patient. If atrial fibrillation is maintained, the patient will receive intravenous procainamide 17 mg / kg over 30 minutes. If the rhythm has changed from atrial fibrillation to normal sinus within one hour, the attending physician may discharge the patient, otherwise a cardiologist will be consulted. | Drug | Electrical-first |
| Chemical-firstAlso: procainamidePatients will be placed on cardiopulmonary blood pressure monitoring, and will receive intravenous procainamide 17 mg / kg over 30 minutes. If the rhythm has changed from atrial fibrillation to normal sinus within one hour, the attending physician may discharge the patient. If the rhythm has not changed, then the patient will be continue to have cardiopulmonary monitoring, but also be attended by a respiratory therapist. The patient will be sedated with propofol 0.5 - 1.0 mg / kg. Once a Ramsay Sedation Scale score of 5 or greater is reached, the physician will attempt synchronized electrical cardioversion with 100 J, 200 J, 200 J. If the patient converts to normal sinus rhythm by the third shock, the physician may discharge the patient, otherwise a cardiologist will be consulted. | Drug | Chemical-first |
Primary outcome
Length-of-stay
Time frame: up to 12 hours
Length of stay is defined as the time from patient randomization to discharge from the emergency department.
1 secondary outcome
Adverse events
Time frame: up to 12 hours after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Scheuermeyer, MD principal investigator
St. Paul's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Electrical-first and Chemical-first in people with Atrial Fibrillation, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length-of-stay (time frame: up to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2015.