Dronaderone to Prevent Recurrent Implantable Cardioverter... | NCT01430806

Studies
Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

NCT01430806

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Sep 8, 2011Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

ICD
ICD SHOCKS
DRONEDARONE

Interventions

Dronedarone arm
Dronedarone

Countries

Not provided

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

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Sep 7, 2011

First Submission Date that Met QC Criteria

Sep 7, 2011

First Posted Date

Sep 8, 2011Estimated

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

Sep 7, 2011

Last Update Posted Date

Sep 8, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

moti haim, Director, Electrophysiology Service,, Rabin Medical CenterPrincipal Investigator

Lead Sponsor

Rabin Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Recurrent ICD shocks are a serious problem in pts with ICD. Treatment failure with other antiarrhythmics and ablation are common. Dronedarone is a new antiarrhythmic drug with ion channel properties similar to amiodarone.

Several case reports have shown promising results with Dronedarone for this patient population.

Detailed Description

Not provided

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dronedrone Arm	Other		Drug: Dronedarone arm Drug: Dronedarone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dronedarone arm	Drug	PO Dronedarone 400 mg BID	Dronedrone Arm
Dronedarone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of ICD shocks due to VT in the 6 months period after starting Dronedarone		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recurernt ICD shocks depite other antiarrhythmic drug therapy

Exclusion Criteria:

CHF NYHA IV OR DECMPENSATED III
PERMANENT AF
LIVER DYSFUNCION
CR CLEARANCE <30

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077764	Dronedarone

Ancestor Terms

ID	Term
D000638	Amiodarone
D001572	Benzofurans
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided