Dynamic Substrate Mapping (DSM) for Ischemic VT

NCT00558857 | Terminated Phase 1

• 1 other identifier: 065.5
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Incidence of serious adverse events (SAEs)

  30 days

Study Arms (1)

DSM

ACTIVE COMPARATOR

Treatment using DSM to guide ablation

Device: Dynamic Substrate Mapping-guided ablation

Interventions

Dynamic Substrate Mapping-guided ablation DEVICE

Radiofrequency ablation

DSM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (3)

Northwestern University

Chicago, Illinois, United States

Location

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Location

Study Officials

• David Callans, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Jason Jacobson, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 15, 2007
• Study Start: July 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

US (3)