Dynamic Substrate Mapping (DSM) for Ischemic VT (DSM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00558857
Recruitment Status : Terminated (Low enrollment)
First Posted : November 15, 2007
Last Update Posted : February 17, 2011
Information provided by:
St. Jude Medical

Brief Summary:
This is a prospective, non-randomized study to determine the feasibility of using a new technique called Dynamic Substrate Mapping (DSM) to help guide the treatment of ischemic ventricular tachycardia (IVT). We hypothesize that DSM will lead to simpler, more effective ablation of IVT. Results from this study will be used to determine if further clinical investigation is warranted.

Condition or disease Intervention/treatment Phase
Ischemic Ventricular Tachycardia Device: Dynamic Substrate Mapping-guided ablation Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Feasibility of Using Dynamic Substrate Mapping to Guide Ablation of Ischemic Ventricular Tachycardia
Study Start Date : July 2007
Primary Completion Date : April 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: DSM
Treatment using DSM to guide ablation
Device: Dynamic Substrate Mapping-guided ablation
Radiofrequency ablation

Primary Outcome Measures :
  1. Incidence of serious adverse events (SAEs) [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have an ICD or CRT-D device
  • Had at least 3 documented device therapies to treat VT over last 3 months
  • Clinical VT is confirmed or suspected to be of ischemic origin
  • Scheduled for VT ablation procedure
  • LVEF > or = 20%

Exclusion Criteria:

  • Inadequate AAD washout (amiodarone should be maintained at current dose)
  • Unstable angina
  • Active ischemia
  • Cardiac surgery within prior 2 months
  • Evidence of infection
  • Prosthetic mitral or aortic valve or mitral/aortic valvular heart disease requiring surgical intervention
  • History of embolic event
  • Myocardial infarction within prior 6 weeks
  • Enrolled in another study
  • Recurrent sepsis or otherwise not a candidate for catheterization
  • Hypercoagulable state or inability to tolerate heparin therapy during procedure
  • Has had an atriotomy or ventriculotomy within prior 4 months
  • Life expectancy < 6 months
  • Class IV NYHA classification

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 identifier (NCT number): NCT00558857

United States, Illinois
Northwestern University
Chicago, Illinois, United States
United States, Pennsylvania
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: David Callans, MD University of Pennsylvania
Principal Investigator: Jason Jacobson, MD Northwestern University

Responsible Party: Donna Godejohn, St. Jude Medical Identifier: NCT00558857     History of Changes
Other Study ID Numbers: 065.5
First Posted: November 15, 2007    Key Record Dates
Last Update Posted: February 17, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Tachycardia, Ventricular
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases