Optimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks (OPTIMA)

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Cardioversion
• Intervention / Treatment: Procedure: 100 joule as first biphasic shock energy; Procedure: 120 joule as first biphasic shock energy

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 Type: Interventional
• Enrollment (Anticipated): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Torino, Italy, 10141
    • Recruiting
    • Cardiology Dpt. Maria Vittoria Hospital
    • Contact: Massimo Imazio, MD; Phone Number: 3391 +39011439; Email: massimo_imazio@yahoo.it
    • Principal Investigator: Massimo Imazio, MD
    • Sub-Investigator: Massimo Giammaria, MD
    • Sub-Investigator: Mara Carraro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 100 joule arm; 100 joule as first biphasic shock energy	Procedure: 100 joule as first biphasic shock energy
Active Comparator: 120 joule arm; 120 joule as first biphasic shock energy	Procedure: 120 joule as first biphasic shock energy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Electrical cardioversion success	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Electrical cardioversion success	3 months
Complications rate	Day 1

Collaborators and Investigators

• Sponsor: Maria Vittoria Hospital
• Investigators: Principal Investigator: Massimo Imazio, MD, Cardiology Dpt. Maria Vittoria Hospital, Torino, Italy

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): March 1, 2014
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: July 24, 2013
• First Submitted That Met QC Criteria: July 29, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Estimate): July 30, 2013
• Last Update Submitted That Met QC Criteria: July 29, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Cardioversion; Biphasic Shock
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 18/04/13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No