Dynamic Substrate Mapping (DSM) for Ischemic VT

NCT ID: NCT00558857

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-04-30

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.

Conditions

Ischemic Ventricular Tachycardia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DSM

Treatment using DSM to guide ablation

Group Type: ACTIVE_COMPARATOR

Dynamic Substrate Mapping-guided ablation

Intervention Type: DEVICE

Radiofrequency ablation

Interventions

Dynamic Substrate Mapping-guided ablation

Radiofrequency ablation

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

St. Jude Medical

Principal Investigators

David Callans, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Jason Jacobson, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

065.5

Identifier Type: -

Identifier Source: org_study_id