Back to resultsOptimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks (OPTIMA)
Primary Purpose
Atrial Fibrillation, Cardioversion
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
100 joule as first biphasic shock energy
120 joule as first biphasic shock energy
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Cardioversion, Biphasic Shock
Eligibility Criteria
Inclusion Criteria:
- Adult (Age>18 years)
- Candidate to Cardioversion for recent onset, persistent atrial fibrillation (>48 hours but < 12 months)
- Informed Consent
Exclusion Criteria:
- Atrial Flutter or other arrythmias
Sites / Locations
- Cardiology Dpt. Maria Vittoria HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
100 joule arm
120 joule arm
Arm Description
100 joule as first biphasic shock energy
120 joule as first biphasic shock energy
Outcomes
Primary Outcome Measures
Electrical cardioversion success
Secondary Outcome Measures
Electrical cardioversion success
Complications rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01910779
Brief Title
Optimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks
Acronym
OPTIMA
Official Title
Optimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks (OPTIMA Trial).
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maria Vittoria Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Cardioversion
Keywords
Atrial Fibrillation, Cardioversion, Biphasic Shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
100 joule arm
Arm Type
Active Comparator
Arm Description
100 joule as first biphasic shock energy
Arm Title
120 joule arm
Arm Type
Active Comparator
Arm Description
120 joule as first biphasic shock energy
Intervention Type
Procedure
Intervention Name(s)
100 joule as first biphasic shock energy
Intervention Type
Procedure
Intervention Name(s)
120 joule as first biphasic shock energy
Primary Outcome Measure Information:
Title
Electrical cardioversion success
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Electrical cardioversion success
Time Frame
3 months
Title
Complications rate
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (Age>18 years)
Candidate to Cardioversion for recent onset, persistent atrial fibrillation (>48 hours but < 12 months)
Informed Consent
Exclusion Criteria:
Atrial Flutter or other arrythmias
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Massimo Imazio, MD
Phone
+39011439
Ext
3391
Email
massimo_imazio@yahoo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Imazio, MD
Organizational Affiliation
Cardiology Dpt. Maria Vittoria Hospital, Torino, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Dpt. Maria Vittoria Hospital
City
Torino
ZIP/Postal Code
10141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Imazio, MD
Phone
+39011439
Ext
3391
Email
massimo_imazio@yahoo.it
First Name & Middle Initial & Last Name & Degree
Massimo Imazio, MD
First Name & Middle Initial & Last Name & Degree
Massimo Giammaria, MD
First Name & Middle Initial & Last Name & Degree
Mara Carraro
12. IPD Sharing Statement
Learn more about this trial
Optimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks
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