Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

NCT ID: NCT01430806

Last Updated: 2011-09-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

ICD; ICD SHOCKS; DRONEDARONE

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dronedrone Arm

Group Type: OTHER

Dronedarone arm

Intervention Type: DRUG

PO Dronedarone 400 mg BID

Dronedarone

Intervention Type: DRUG

Dronedarone PO 400 MG BID

Interventions

Dronedarone arm

PO Dronedarone 400 mg BID

Intervention Type: DRUG

Dronedarone

Dronedarone PO 400 MG BID

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

moti haim

Director, Electrophysiology Service,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

6402

Identifier Type: -

Identifier Source: org_study_id