Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

Clalit Health Services

Status: Unknown

Conditions: ICD SHOCKS; DRONEDARONE; ICD

Treatments: Drug: Dronedarone; Drug: Dronedarone arm

Study type: Interventional

Funder types: Other

Identifiers

NCT01430806

6402

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Dronedrone Arm

Other group

Treatment:

Drug: Dronedarone

Drug: Dronedarone arm