Ventricular TachycardiaEPILOGUENCT02358746
Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First Procedure Versus a Stepwise Approach
A study testing combined endo/epicardial approach and stepwise approach in people with Ventricular Tachycardia and Ischemic Cardiomyopathy, run by Erasmus Medical Center.
Trial summary
Rationale: Nowadays ventricular tachycardia (VT) ablation in structural heart disease is performed primarily by early referral; while at the same time we still struggle with the limited longterm ablation success of endocardial VT ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- What is being tested?
- combined endo/epicardial approach and stepwise approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2019
- Phase
- Interventional
- 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
Who may be able to join
- clinical indication for ablation of a monomorphic ventricular tachycardia referred to one of the participating ablation centers
- history of ischemic heart disease
- ICD carrier or ICD implantation planned after the ablation
- informed written consent
Who cannot join
- current unstable angina as defined by current european guidelines
- AMI < 30 days or in case of incessant VT < 14 days
- absence of visualisation of the coronary anatomy (coronary angiogram /CT-angiogram)
- significant coronary stenosis approachable and clinically relevant for intervention
- presence of a mobile left ventricle thrombus seen on (contrast) echocardiography or MRI
- previous pericarditis
Show all 10Show fewer
- presence of mitral/aortic mechanical valves prosthesis; previous coronary artery bypass graft; any other thoracic surgery that could cause pericardial adhesions
- previous thoracic radiation therapy
- contra-indication for general anaesthesia
- age below 18 years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First Procedure Versus a Stepwise Approach a Randomized Controlled Trial
Rationale: Nowadays ventricular tachycardia (VT) ablation in structural heart disease is performed primarily by early referral; while at the same time we still struggle with the limited longterm ablation success of endocardial VT ablation. An underestimated number of VTs from ischemic substrate have an epicardial exit. However, one cannot accurately predict who is in need of epicardial ablation. The investigators hypothesise endo/epicardial substrate homogenization in a first approach to be superior to endocardial substrate homogenization alone, in terms of recurrence on follow-up.
Objective: To show superiority of a combined endo/epicardial approach compared to a stepwise approach in the ablation of ventricular tachycardia in a population with ischemic cardiomyopathy on VT recurrence.
Read more
Study design: Multicenter prospective open randomized controlled trial. Study population: All patients above 18 years with an ischemic cardiomyopathy being referred for a ventricular tachycardia ablation.
Intervention: One group undergoes endo/epicardial ablation and the other group has endocardial ablation only as a first approach.
Main study parameters/endpoints: The main study endpoint is the difference in recurrences of ventricular tachycardia on follow-up - clinical or on implantable cardioverter defibrillator (ICD) interrogation - between the two ablation groups; secondary endpoints are procedure success and safety.
- Conditions
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- Being tested
- combined endo/epicardial approach, stepwise approach
- Keywords
- epicardial catheter 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.
combined endo/epicardial approachOther
Also called endo /epicardial catheter ablation
stepwise approachOther
endocardial scar homogenization only at the first VT ablation procedure
| Study group | Role | What they receive |
|---|---|---|
| combined endo/epicardial approach | Experimental | combining endocardial scar homogenization with epicardial scar homogenization in the first VT ablation approach Receives: Other: combined endo/epicardial approach |
| stepwise approach | Active comparator | endocardial scar homogenization only at the first VT ablation procedure Receives: Other: stepwise approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence (Recurrence of any ventricular tachycardia)
Recurrence of any ventricular tachycardia: any appropriate ICD therapy or VT > 30 seconds of duration recorded by ICD interrogations or on clinical event recorded by electrocardiogram with an initial blanking period of 1 week after the ablation procedure
Measured: 2 years
Secondary outcomes (10)
procedure success
success: non-inducibility of any sustained monomorphic VT partial success: non-inducibility of clinical VT (inducibility of non-clinical VT excluding polymorphic VT, VT with cycle length < 200ms)
Measured: 2 years
procedure related (serious) adverse events
major: death, acute myocardial infarction (AMI) / coronary artery damage, major bleeding - type III and V, abdominal bleeding, tamponade > 80cm3, late tamponade, ischemic cerebral event minor: dry right ventricle puncture, drainable hemopericardium, postprocedural precordial pain, phrenic nerve injury, minor bleeding - type II
Measured: 30 days
procedure time, fluoroscopy and radiofrequency time
Measured: one day
time to recurrence to ventricular arrhythmia
Measured: 2 years
number of appropriate ICD therapy on follow-up
Measured: 2 years
number of ventricular arrhythmia related hospitalizations
Measured: 2 years
free of antiarrhythmic drugs on follow-up
Measured: 2 years
repeat procedure
Measured: 2 years
incessant VT or VT storm on follow-up
Measured: 2 years
mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Astrid Hendriks, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358746
- Sponsor's protocol ID
- NL48168.078.14
- Acronym
- EPILOGUE
- Status last verified
- Feb 2015
- First submitted
- 27 Jan 2015
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First Procedure Versus a Stepwise Approach a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02358746
- Acronym / sponsor ID
- EPILOGUE / NL48168.078.14
- Conditions
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- Keywords
- epicardial catheter ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 Feb 2015 (estimated)
- 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.
Rationale: Nowadays ventricular tachycardia (VT) ablation in structural heart disease is performed primarily by early referral; while at the same time we still struggle with the limited longterm ablation success of endocardial VT ablation. An underestimated number of VTs from ischemic substrate have an epicardial exit. However, one cannot accurately predict who is in need of epicardial ablation. The investigators hypothesise endo/epicardial substrate homogenization in a first approach to be superior to endocardial substrate homogenization alone, in terms of recurrence on follow-up.
Objective: To show superiority of a combined endo/epicardial approach compared to a stepwise approach in the ablation of ventricular tachycardia in a population with ischemic cardiomyopathy on VT recurrence.
Study design: Multicenter prospective open randomized controlled trial. Study population: All patients above 18 years with an ischemic cardiomyopathy being referred for a ventricular tachycardia ablation.
Intervention: One group undergoes endo/epicardial ablation and the other group has endocardial ablation only as a first approach.
Main study parameters/endpoints: The main study endpoint is the difference in recurrences of ventricular tachycardia on follow-up - clinical or on implantable cardioverter defibrillator (ICD) interrogation - between the two ablation groups; secondary endpoints are procedure success and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined endo/epicardial approach | Experimental | Other: combined endo/epicardial approachcombining endocardial scar homogenization with epicardial scar homogenization in the first VT ablation approach |
| stepwise approach | Active comparator | Other: stepwise approachendocardial scar homogenization only at the first VT ablation procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical indication for ablation of a monomorphic ventricular tachycardia referred to one of the participating ablation centers
- history of ischemic heart disease
- ICD carrier or ICD implantation planned after the ablation
- informed written consent
Key exclusion criteria (10 listed)
- current unstable angina as defined by current european guidelines
- AMI < 30 days or in case of incessant VT < 14 days
- absence of visualisation of the coronary anatomy (coronary angiogram /CT-angiogram)
- significant coronary stenosis approachable and clinically relevant for intervention
- presence of a mobile left ventricle thrombus seen on (contrast) echocardiography or MRI
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 |
|---|---|---|
| combined endo/epicardial approachAlso: endo /epicardial catheter ablation | Other | combined endo/epicardial approach |
| stepwise approachendocardial scar homogenization only at the first VT ablation procedure | Other | stepwise approach |
Primary outcome
Recurrence (Recurrence of any ventricular tachycardia)
Time frame: 2 years
Recurrence of any ventricular tachycardia: any appropriate ICD therapy or VT > 30 seconds of duration recorded by ICD interrogations or on clinical event recorded by electrocardiogram with an initial blanking period of 1 week after the ablation procedure
10 secondary outcomes
procedure success
Time frame: 2 years
procedure related (serious) adverse events
Time frame: 30 days
procedure time, fluoroscopy and radiofrequency time
Time frame: one day
time to recurrence to ventricular arrhythmia
Time frame: 2 years
number of appropriate ICD therapy on follow-up
Time frame: 2 years
number of ventricular arrhythmia related hospitalizations
Time frame: 2 years
free of antiarrhythmic drugs on follow-up
Time frame: 2 years
repeat procedure
Time frame: 2 years
incessant VT or VT storm on follow-up
Time frame: 2 years
mortality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing combined endo/epicardial approach and stepwise approach in people with Ventricular Tachycardia and Ischemic Cardiomyopathy, run by Erasmus Medical Center.
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 4 inclusion and 10 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 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Astrid Hendriks, MD (0031107032710, a.a.hendriks@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (Recurrence of any ventricular tachycardia) (time frame: 2 years). 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 Feb 2015.