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Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (nsVT)

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ClinicalTrials.gov Identifier: NCT03147027
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Brief Summary:
Despite established implantable cardioverter-defibrillator (ICD) therapy and catheter ablation for sustained ventricular tachycardia (VT) in patients with ischemic heart disease (IHD) and reduced left ventricular ejection fraction (LVEF), the efficacy of catheter ablation in patients with nonsustained VT has been not yet clarified. The incidence of appropriate ICD therapy itself has been reported to be a worse prognostic factor in patients with reduced LVEF. Therefore theoretically the inhibition of these ventricular incidences can result in the prognostic improvement.To suppress ventricular arrhythmias aside from antiarrhythmic agents, catheter ablation has been developed prominently in this decade along with the technological improvement such as irrigated ablation catheters, three-dimensional mapping systems, multi-polar catheters, and image integration system with CT and MRI. The rationale of this trial is to study the efficacy of the eradication of arrhythmogenic substrate in ischemic cardiomyopathy with reduced LVEF and nonsustained VT on prevention of the occurrence of sustained VT/VF and ICD therapies.

Condition or disease Intervention/treatment
Ventricular Tachycardia Ischemic Cardiomyopathy Reduced LVEF Procedure: VT ablation Other: medication

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Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Group/Cohort Intervention/treatment
VT ablation group Procedure: VT ablation
Substrate mapping for VT will be performed with the CARTO electroanatomical system.

medication group Other: medication
medication to prevent sustained VT and ICD therapies




Primary Outcome Measures :
  1. occurrence of sustained VT/VF or ICD therapy [ Time Frame: time from randomization to occurrence of any sustained VT/VF within 24 months ]
    occurrence of sustained VT/VF or ICD therapy including ATP and shock


Secondary Outcome Measures :
  1. survival free from clinical events [ Time Frame: time from randomization to 24 months ]
    survival free from clinical events (death, syncope, hospital admission due to cardiac problems, and VT storm, defined as more than three VT episodes in 24 hours)

  2. number of appropriate ICD therapies [ Time Frame: time from randomization to 24 months ]
    number of appropriate ICD therapies (ATP or shock)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with nonsustained VT and ischemic cardiomyopathy and reduced LVEF
Criteria

Inclusion Criteria:

  • left ventricular ejection fraction (TTE or MRI) ≤40%
  • diagnosed ischemic heart disease
  • nonsustained monomorphic VT with more than 5 beats in the record of the implantable cardioverter-defibrillator or in any means of electrocardiogram (ECG) including ECG monitor and holter monitoring
  • ICD implantation with primary preventive indication

Exclusion Criteria:

  • ICD implantation within 2 months
  • previously documented sustained VT/VF (over 30 seconds) or adequate ICD shock
  • no written informed consent

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): NCT03147027


Contacts
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Contact: Hisaki Makimoto, MD +492118118800 hisaki.makimoto@med.uni-duesseldorf.de
Contact: Rabea Wagstaff, MA +492118118800 rabea.wagstaff@med.uni-duesseldorf.de

Locations
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Germany
Division of Cardiology, Pulmonary Disease and Vascular Medicine Recruiting
Düsseldorf, Germany, 40225
Contact: Hisaki Makimoto, MD         
Contact: Rabea Wagstaff, M.A.         
Principal Investigator: Hisaki Makimoto, MD         
Sub-Investigator: Alexander Fürnkranz, MD         
Sub-Investigator: Patrick Müller, MD         
Sub-Investigator: Lukas Clasen, MD         
Sub-Investigator: Jan Schmidt, MD         
Sub-Investigator: Muhammed Kurt, MD         
Sub-Investigator: Christoph Brinkmeyer, MD         
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf

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Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Principal Investigator, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT03147027     History of Changes
Other Study ID Numbers: 15-007
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
ischemic cardiomyopathy
prophylactic 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