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

Maria Vittoria Hospital

Status: Unknown

Conditions: Atrial Fibrillation; Cardioversion

Treatments: Procedure: 120 joule as first biphasic shock energy; Procedure: 100 joule as first biphasic shock energy

Study type: Interventional

Funder types: Other

Identifiers

NCT01910779

18/04/13

Details and patient eligibility

About

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.

Full 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).

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

100 joule arm

Active Comparator group

Description:

100 joule as first biphasic shock energy

Treatment:

Procedure: 100 joule as first biphasic shock energy

120 joule arm

Active Comparator group

Description:

120 joule as first biphasic shock energy

Treatment:

Procedure: 120 joule as first biphasic shock energy