Amiodarone Usage After Ischemic Ventricular Tachycardia Ablation

NCT ID: NCT03244748

Last Updated: 2017-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ischemic Cardiomyopathy Ventricular Tachycardia ICD Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients underwent ablation and continued having amiodarone after the procedure

Ventricular tachycardia ablation

Intervention Type PROCEDURE

Electrophysiologic procedure aims to ablate and terminate arrhythmia percutaneously

Group 2

Patients underwent ablation and not having amiodarone after the procedure

Ventricular tachycardia ablation

Intervention Type PROCEDURE

Electrophysiologic procedure aims to ablate and terminate arrhythmia percutaneously

Interventions

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Ventricular tachycardia ablation

Electrophysiologic procedure aims to ablate and terminate arrhythmia percutaneously

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuksek Ihtisas Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fırat Özcan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Firat Ozcan, MD

Role: PRINCIPAL_INVESTIGATOR

MD

Locations

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Turkiye Yuksek Ihtisas Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Firat Ozcan, Ass. Prof, MD

Role: CONTACT

+905327854000

Facility Contacts

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Firat Ozcan, Ass. Prof, MD

Role: primary

5327854000

Other Identifiers

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ozcan01

Identifier Type: -

Identifier Source: org_study_id

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