NCT01910779

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

10 months

First QC Date

July 24, 2013

Last Update Submit

July 29, 2013

Conditions

Atrial FibrillationCardioversion

Keywords

Atrial FibrillationCardioversionBiphasic Shock

Outcome Measures

Primary Outcomes (1)

  • Electrical cardioversion success

    Day 1

Secondary Outcomes (2)

  • Electrical cardioversion success

    3 months

  • Complications rate

    Day 1

Study Arms (2)

100 joule arm

ACTIVE COMPARATOR

100 joule as first biphasic shock energy

Procedure: 100 joule as first biphasic shock energy

120 joule arm

ACTIVE COMPARATOR

120 joule as first biphasic shock energy

Procedure: 120 joule as first biphasic shock energy

Interventions

100 joule as first biphasic shock energyPROCEDURE
100 joule arm
120 joule as first biphasic shock energyPROCEDURE
120 joule arm

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Atrial Flutter or other arrythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Dpt. Maria Vittoria Hospital

Torino, Torino, 10141, Italy

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Massimo Imazio, MD

    Cardiology Dpt. Maria Vittoria Hospital, Torino, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimo Imazio, MD

CONTACT

+39011439massimo_imazio@yahoo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 24, 2013

First Posted

July 30, 2013

Study Start

May 1, 2013

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations

IT(1)