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Dynamic Substrate Mapping (DSM) for Ischemic VT

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00558857
First received: November 14, 2007
Last updated: February 16, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention Phase
Ischemic Ventricular Tachycardia
 Device: Dynamic Substrate Mapping-guided ablation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Feasibility of Using Dynamic Substrate Mapping to Guide Ablation of Ischemic Ventricular Tachycardia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Incidence of serious adverse events (SAEs) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: July 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DSM
Treatment using DSM to guide ablation
 Device: Dynamic Substrate Mapping-guided ablation
Radiofrequency ablation

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558857

Locations
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
Investigators
Principal Investigator: David Callans, MD University of Pennsylvania
Principal Investigator: Jason Jacobson, MD Northwestern University
  More Information

No publications provided

Responsible Party: Donna Godejohn, St. Jude Medical
ClinicalTrials.gov Identifier: NCT00558857     History of Changes
Other Study ID Numbers: 065.5
Study First Received: November 14, 2007
Last Updated: February 16, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013