Ischemic CardiomyopathyNCT03244748
Amiodarone Usage After Ischemic Ventricular Tachycardia Ablation
An observational study of Ischemic Cardiomyopathy and Ventricular Tachycardia, run by Yuksek Ihtisas Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Cardiomyopathy, Ventricular Tachycardia, ICD Shock
- What is being tested?
- Ventricular tachycardia ablation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 1 Mar 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We enroll ischemic heart failure patients who had frequent ventricular arrhythymias causing multiple shocks.
Who may be able to join
- 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.
Who cannot join
- Patients with cardiomyopathies other than ischemic etiology
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Turkiye Yuksek Ihtisas Training and Research Hospital
Ankara, 06590
Firat Ozcan, Ass. Prof, MD, 5327854000, drfozcan@gmail.com
About this study
Official title: Effect of Amiodarone After Ischemic Ventricular Tachycardia Ablation
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.
Read the detailed 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.
- Conditions
- Ischemic Cardiomyopathy, Ventricular Tachycardia, ICD Shock
- Being tested
- Ventricular tachycardia ablation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventricular tachycardia ablationProcedure or surgery
Electrophysiologic procedure aims to ablate and terminate arrhythmia percutaneously
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients underwent ablation and continued having amiodarone after the procedure Receives: Procedure: Ventricular tachycardia ablation | |
| Group 2 | Patients underwent ablation and not having amiodarone after the procedure Receives: Procedure: Ventricular tachycardia ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Death, ICD intervetion
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start1 Jan 2016
- Primary completion1 Jan 2018 (estimated)
- Study completion1 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fırat Özcan, Yuksek Ihtisas Hospital
- Investigators
- Firat Ozcan, MD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244748
- Sponsor's protocol ID
- ozcan01
- Status last verified
- Aug 2017
- First submitted
- 5 Aug 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amiodarone After Ischemic Ventricular Tachycardia Ablation
- ClinicalTrials.gov ID
- NCT03244748
- Acronym / sponsor ID
- ozcan01
- Conditions
- Ischemic Cardiomyopathy, Ventricular Tachycardia, ICD Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yuksek Ihtisas HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 1 Mar 2018 (estimated)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Ventricular tachycardia ablationPatients underwent ablation and continued having amiodarone after the procedure |
| Group 2 | – | Procedure: Ventricular tachycardia ablationPatients underwent ablation and not having amiodarone after the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We enroll ischemic heart failure patients who had frequent ventricular arrhythymias causing multiple shocks.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with cardiomyopathies other than ischemic etiology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventricular tachycardia ablationElectrophysiologic procedure aims to ablate and terminate arrhythmia percutaneously | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Major adverse cardiovascular events
Time frame: six months
Death, ICD intervetion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Firat Ozcan, MD principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Cardiomyopathy and Ventricular Tachycardia, run by Yuksek Ihtisas Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Firat Ozcan, Ass. Prof, MD (+905327854000, drfozcan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017; AzTrials last refreshed its copy on 27 Oct 2026.