Dynamic Substrate Mapping (DSM) for Ischemic VT - Full Text View

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00558857

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 I

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Clinical Feasibility of Using Dynamic Substrate Mapping to Guide Ablation of Ischemic Ventricular Tachycardia

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Incidence of serious adverse events (SAEs) [ Time Frame: 30 days ]

Secondary Outcome Measures:

Non-inducibility of clinical VT [ Time Frame: Procedure ]

Enrollment:	3
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2009

Arms	Assigned Interventions
DSM: Active Comparator 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

Study ID Numbers:	065.5
Study First Received:	November 14, 2007
Last Updated:	November 14, 2007
ClinicalTrials.gov Identifier:	NCT00558857
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Heart Diseases
Tachycardia
Ischemia
Tachycardia, Ventricular
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009