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

Atrial Fibrillation Clinical Trial

— OPTIMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01910779
• Other study ID #: 18/04/13
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2013
• Last updated: July 29, 2013
• Start date: May 2013
• Est. completion date: April 2014

Study information

• Verified date: July 2013
• Source: Maria Vittoria Hospital
• Contact: Massimo Imazio, MD
• Phone: +39011439
• Email: massimo_imazio[@]yahoo.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardioversion

Intervention

Procedure:
• 100 joule as first biphasic shock energy

• 120 joule as first biphasic shock energy

Locations

Country	Name	City	State
Italy	Cardiology Dpt. Maria Vittoria Hospital	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Maria Vittoria Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrical cardioversion success		Day 1	No
Secondary	Electrical cardioversion success		3 months	No
Secondary	Complications rate		Day 1	Yes