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Status unknownNCT01910779OPTIMAUpdated Jul 30, 2013

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

An interventional study of 100 joule as first biphasic shock energy and 120 joule as first biphasic shock energy in Atrial Fibrillation and Cardioversion, sponsored by Maria Vittoria Hospital. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-07-30.

Sponsored by Maria Vittoria Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Atrial Fibrillation
  • Cardioversion

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Keywords

  • Atrial Fibrillation
  • Cardioversion
  • Biphasic Shock
03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 154 is close to the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Maria Vittoria Hospital is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult (Age>18 years)
  • Candidate to Cardioversion for recent onset, persistent atrial fibrillation (>48 hours but \< 12 months)

Exclusion criteria

Exclusion Criteria:

  • Atrial Flutter or other arrythmias
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
154 participants (estimated)

Study arms

  • 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

Interventions

  • Procedure100 joule as first biphasic shock energy
  • Procedure120 joule as first biphasic shock energy
06

What researchers measure

Primary outcomes

  1. Electrical cardioversion success

    Time frame: Day 1

Secondary outcomes

  1. Electrical cardioversion success

    Time frame: 3 months

  2. Complications rate

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
  • Cardiology Dpt. Maria Vittoria Hospital
    Torino, 10141, Italy
    Recruiting
    • Massimo Imazio, MD · Contactmassimo_imazio@yahoo.it · +39011439
    • Massimo Imazio, MD · Principal investigator
    • Massimo Giammaria, MD · Sub investigator
    • Mara Carraro · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2013, a primary completion of Mar 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2013
First posted
Jul 30, 2013
Start
May 2013
Primary completionEst.
Mar 2014
CompletionEst.
Apr 2014
Last update
Jul 30, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01910779
Lead sponsor
Maria Vittoria Hospital
Responsible party
Massimo Imazio (MD, Maria Vittoria Hospital) — Principal investigator
First posted
Jul 30, 2013
Start date
May 2013
Primary completion
Mar 2014 (estimated)
Completion
Apr 2014 (estimated)
Last update
Jul 30, 2013

Study contacts

Massimo Imazio, MD
Contact
massimo_imazio@yahoo.it
+39011439 ext. 3391
Massimo Imazio, MD
principal investigator · Cardiology Dpt. Maria Vittoria Hospital, Torino, Italy

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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