Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks

Dronedarone for Patients With Recurrent ICD Shocks Due to Ventricular Arrhythmia Resistant to Their Antiarrhythmic Drug Therapy or Ablation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01430806

Enrollment

Registered

2011-09-08

Start date

2011-10-31

Completion date

2015-12-31

Last updated

2011-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICD, ICD SHOCKS, DRONEDARONE

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.

Interventions

DRUGDronedarone arm

PO Dronedarone 400 mg BID

DRUGDronedarone

Dronedarone PO 400 MG BID

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026