Atrial FibrillationOPTIMANCT01910779
Optimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks
A study testing 100 joule as first biphasic shock energy and 120 joule as first biphasic shock energy in people with Atrial Fibrillation and Cardioversion, run by Maria Vittoria Hospital at 1 site in Italy.
Trial summary
Use of higher energy doses (120-150 J) may not offer additional benefits and higher success rate compared with low to moderate initial energy (100-120 J) of biphasic shock for atrial fibrillation cardioversion. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrial Fibrillation, Cardioversion
- What is being tested?
- 100 joule as first biphasic shock energy and 120 joule as first biphasic shock energy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Apr 2014
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (Age>18 years)
- Candidate to Cardioversion for recent onset, persistent atrial fibrillation (>48 hours but < 12 months)
- Informed Consent
Who cannot join
- Atrial Flutter or other arrythmias
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Cardiology Dpt. Maria Vittoria Hospital
Torino, Torino, 10141
Massimo Imazio, MD, +39011439 ext. 3391, massimo_imazio@yahoo.it
Massimo Imazio, MD
About this study
Official title: Optimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks (OPTIMA Trial).
Use of higher energy doses (120-150 J) may not offer additional benefits and higher success rate compared with low to moderate initial energy (100-120 J) of biphasic shock for atrial fibrillation cardioversion. In this prospective open-label randomized trial consecutive patients with AF and candidate to AF electrical cardioversion will be randomized to receive 100J or 120 J as initial dose of biphasic shock. Patients will be also randomized in each group to anterolateral or postero-anteriore placement of defibrillator electrodes.
Read the detailed description
Open-label randomized trial to assess the efficacy of alternative initial biphasic shocks (100 versus 120 J) for cardioversion of atrial fibrillation including alternative option for electrode placement (anterolateral or postero-anterior in each group).
- Conditions
- Atrial Fibrillation, Cardioversion
- Being tested
- 100 joule as first biphasic shock energy, 120 joule as first biphasic shock energy
- Keywords
- Atrial Fibrillation, Cardioversion, Biphasic Shock
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 joule as first biphasic shock energyProcedure or surgery
120 joule as first biphasic shock energyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 100 joule arm | Active comparator | 100 joule as first biphasic shock energy Receives: Procedure: 100 joule as first biphasic shock energy |
| 120 joule arm | Active comparator | 120 joule as first biphasic shock energy Receives: Procedure: 120 joule as first biphasic shock energy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical cardioversion success
Measured: Day 1
Secondary outcomes (2)
Electrical cardioversion success
Measured: 3 months
Complications rate
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2014 (estimated)
- Study completionApr 2014 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Vittoria Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Imazio, Maria Vittoria Hospital
- Investigators
- Massimo Imazio, MD, Principal investigator, Cardiology Dpt. Maria Vittoria Hospital, Torino, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910779
- Sponsor's protocol ID
- 18/04/13
- Acronym
- OPTIMA
- Status last verified
- Jul 2013
- First submitted
- 24 Jul 2013
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks (OPTIMA Trial).
- ClinicalTrials.gov ID
- NCT01910779
- Acronym / sponsor ID
- OPTIMA / 18/04/13
- Conditions
- Atrial Fibrillation, Cardioversion
- Keywords
- Atrial Fibrillation, Cardioversion, Biphasic Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Maria Vittoria HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 30 Jul 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.
Use of higher energy doses (120-150 J) may not offer additional benefits and higher success rate compared with low to moderate initial energy (100-120 J) of biphasic shock for atrial fibrillation cardioversion. In this prospective open-label randomized trial consecutive patients with AF and candidate to AF electrical cardioversion will be randomized to receive 100J or 120 J as initial dose of biphasic shock. Patients will be also randomized in each group to anterolateral or postero-anteriore placement of defibrillator electrodes.
Detailed description
Open-label randomized trial to assess the efficacy of alternative initial biphasic shocks (100 versus 120 J) for cardioversion of atrial fibrillation including alternative option for electrode placement (anterolateral or postero-anterior in each group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 joule arm | Active comparator | Procedure: 100 joule as first biphasic shock energy100 joule as first biphasic shock energy |
| 120 joule arm | Active comparator | Procedure: 120 joule as first biphasic shock energy120 joule as first biphasic shock energy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (Age>18 years)
- Candidate to Cardioversion for recent onset, persistent atrial fibrillation (>48 hours but < 12 months)
- Informed Consent
Key exclusion criteria (1 listed)
- Atrial Flutter or other arrythmias
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 |
|---|---|---|
| 100 joule as first biphasic shock energy | Procedure or surgery | 100 joule arm |
| 120 joule as first biphasic shock energy | Procedure or surgery | 120 joule arm |
Primary outcome
Electrical cardioversion success
Time frame: Day 1
2 secondary outcomes
Electrical cardioversion success
Time frame: 3 months
Complications rate
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
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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.
Massimo Imazio, MD principal investigator
Cardiology Dpt. Maria Vittoria Hospital, Torino, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100 joule as first biphasic shock energy and 120 joule as first biphasic shock energy in people with Atrial Fibrillation and Cardioversion, run by Maria Vittoria Hospital at 1 site in Italy.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Jul 2013. 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 Italy. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Massimo Imazio, MD (+39011439 ext. 3391, massimo_imazio@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrical cardioversion success (time frame: Day 1). 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 30 Jul 2013.