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Optimization of Initial Energy for Cardioversion of Atrial Fibrillation With Biphasic Shocks

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01910779
Acronym
OPTIMA
Enrollment
154
Registered
2013-07-30
Start date
2013-05-31
Completion date
2014-04-30
Last updated
2013-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Cardioversion

Keywords

Atrial Fibrillation, Cardioversion, Biphasic Shock

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).

Interventions

PROCEDURE100 joule as first biphasic shock energy
PROCEDURE120 joule as first biphasic shock energy

Sponsors

Maria Vittoria Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Electrical cardioversion successDay 1

Secondary

MeasureTime frame
Electrical cardioversion success3 months
Complications rateDay 1

Countries

Italy

Contacts

Primary ContactMassimo Imazio, MD
massimo_imazio@yahoo.it+39011439

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026