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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03244748
Other study ID # ozcan01
Secondary ID
Status Recruiting
Phase N/A
First received August 5, 2017
Last updated August 5, 2017
Start date January 1, 2016
Est. completion date March 1, 2018

Study information

Verified date August 2017
Source Yuksek Ihtisas Hospital
Contact Firat Ozcan, Ass. Prof, MD
Phone +905327854000
Email drfozcan@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Ventricular Tachycardia ablation in ischemic cardiomyopathy patients is required procedure in cases when anti-arrhythmic drugs failed. The concern is if adjunctive continuation amiodarone after ablation is needed.


Description:

Ischemic cardiomyopathy patients have implantable cardioverter defibrillators (ICD) to prevent arrhythmic deaths. Ventricular tachycardia (VT) events with frequent ICD interventions in ischemic cardiomyopathy patients is encountered frequently. Frequents ICD interventions is associated with worse outcomes. Anti-arrhythmic drugs ,mostly amiodarone, are given prevent ventricular arrhythmias and ICD interventions that may not be curative. Ablation of ventricular tachycardia is the suggested treatment when anti-drugs are without effect. After ablation of ventricular arrhythmia the continuation of amiodarone is not well elucidated.

In this study we aimed to enroll ischemic cardiomyopathy patients having frequent ICD interventions despite medical treatment. VT ablation is performed and patients divided into two groups; group one continues having amiodarone after ablation, group two does not have amiodarone after ablation. Both groups will be compared in terms of recurrence and death.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 1, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Ischemic cardiomyopathy patients applied with frequent ICD interventionor electrical storms and having ejection fraction below 50%. Frequent ICD defined as more than 1 ICD intervention within month. Electrical storm defined as more than 2 ICD intervention within one day.

Exclusion Criteria:

Patients with cardiomyopathies other than ischemic etiology

Study Design


Intervention

Procedure:
Ventricular tachycardia ablation
Electrophysiologic procedure aims to ablate and terminate arrhythmia percutaneously

Locations

Country Name City State
Turkey Turkiye Yuksek Ihtisas Training and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Yuksek Ihtisas Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major adverse cardiovascular events Death, ICD intervetion six months
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