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Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First Procedure Versus a Stepwise Approach (EPILOGUE)

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ClinicalTrials.gov Identifier: NCT02358746
Recruitment Status : Not yet recruiting
First Posted : February 9, 2015
Last Update Posted : February 9, 2015
Sponsor:
Information provided by (Responsible Party):
Astrid Hendriks, Erasmus Medical Center

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Ischemic Cardiomyopathy Other: combined endo/epicardial approach Other: stepwise approach Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First Procedure Versus a Stepwise Approach a Randomized Controlled Trial
Study Start Date : May 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
Experimental: combined endo/epicardial approach
combining endocardial scar homogenization with epicardial scar homogenization in the first VT ablation approach
Other: combined endo/epicardial approach
Other Name: endo /epicardial catheter ablation

Active Comparator: stepwise approach
endocardial scar homogenization only at the first VT ablation procedure
Other: stepwise approach
endocardial scar homogenization only at the first VT ablation procedure




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. procedure success [ Time Frame: 2 years ]
    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)

  2. procedure related (serious) adverse events [ Time Frame: 30 days ]
    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

  3. procedure time, fluoroscopy and radiofrequency time [ Time Frame: one day ]
  4. time to recurrence to ventricular arrhythmia [ Time Frame: 2 years ]
  5. number of appropriate ICD therapy on follow-up [ Time Frame: 2 years ]
  6. number of ventricular arrhythmia related hospitalizations [ Time Frame: 2 years ]
  7. free of antiarrhythmic drugs on follow-up [ Time Frame: 2 years ]
  8. repeat procedure [ Time Frame: 2 years ]
  9. incessant VT or VT storm on follow-up [ Time Frame: 2 years ]
  10. mortality [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. clinical indication for ablation of a monomorphic ventricular tachycardia referred to one of the participating ablation centers
  2. history of ischemic heart disease
  3. ICD carrier or ICD implantation planned after the ablation
  4. informed written consent

Exclusion Criteria:

  1. current unstable angina as defined by current european guidelines
  2. AMI < 30 days or in case of incessant VT < 14 days
  3. absence of visualisation of the coronary anatomy (coronary angiogram /CT-angiogram)
  4. significant coronary stenosis approachable and clinically relevant for intervention
  5. presence of a mobile left ventricle thrombus seen on (contrast) echocardiography or MRI
  6. previous pericarditis
  7. presence of mitral/aortic mechanical valves prosthesis; previous coronary artery bypass graft; any other thoracic surgery that could cause pericardial adhesions
  8. previous thoracic radiation therapy
  9. contra-indication for general anaesthesia
  10. age below 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358746


Contacts
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Contact: Astrid Hendriks, MD 0031107032710 a.a.hendriks@erasmusmc.nl
Contact: Tamas Szilil-Torok, MD, PhD 031107035018 t.szilitorok@erasmusmc.nl

Sponsors and Collaborators
Erasmus Medical Center

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Responsible Party: Astrid Hendriks, MD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02358746     History of Changes
Other Study ID Numbers: NL48168.078.14
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: February 9, 2015
Last Verified: February 2015
Keywords provided by Astrid Hendriks, Erasmus Medical Center:
epicardial catheter ablation
Additional relevant MeSH terms:
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Cardiomyopathies
Tachycardia
Tachycardia, Ventricular
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease