NCT03244748

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

August 5, 2017

Last Update Submit

August 5, 2017

Conditions

Ischemic CardiomyopathyVentricular TachycardiaICD Shock

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular events

    Death, ICD intervetion

    six months

Study Arms (2)

Group 1

Patients underwent ablation and continued having amiodarone after the procedure

Procedure: Ventricular tachycardia ablation

Group 2

Patients underwent ablation and not having amiodarone after the procedure

Procedure: Ventricular tachycardia ablation

Interventions

Ventricular tachycardia ablationPROCEDURE

Electrophysiologic procedure aims to ablate and terminate arrhythmia percutaneously

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We enroll ischemic heart failure patients who had frequent ventricular arrhythymias causing multiple shocks.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with cardiomyopathies other than ischemic etiology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkiye Yuksek Ihtisas Training and Research Hospital

Ankara, 06590, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Firat Ozcan, MD

    MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Firat Ozcan, Ass. Prof, MD

CONTACT

+905327854000drfozcan@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 5, 2017

First Posted

August 9, 2017

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

August 9, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)