Optimization of Initial Energy for Cardioversion of Atria... | NCT01910779

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

NCT01910779

Sponsor

Maria Vittoria Hospital

Status

Unknown status

Last Update Posted

Jul 30, 2013Estimated

Enrollment

154Estimated

Phase

Not Applicable

Conditions

Atrial Fibrillation
Cardioversion

Interventions

100 joule as first biphasic shock energy
120 joule as first biphasic shock energy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Mar 2014Estimated

Completion Date

Apr 2014Estimated

First Submitted Date

Jul 24, 2013

First Submission Date that Met QC Criteria

Jul 29, 2013

First Posted Date

Jul 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2013

Last Update Posted Date

Jul 30, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

154Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
100 joule as first biphasic shock energy	Procedure		100 joule arm
120 joule as first biphasic shock energy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Electrical cardioversion success		Day 1

Secondary Outcomes

Measure	Description	Time Frame
Electrical cardioversion success		3 months
Complications rate		Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Massimo Imazio, MD	Contact	+39011439	3391	massimo_imazio@yahoo.it

Overall Officials

Name	Affiliation	Role
Massimo Imazio, MD	Cardiology Dpt. Maria Vittoria Hospital, Torino, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology Dpt. Maria Vittoria Hospital	Recruiting	Torino	Torino	10141	Italy

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided