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

Primary Purpose

Ischemic Ventricular Tachycardia

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dynamic Substrate Mapping-guided ablation

About this trial

This is an interventional treatment trial for Ischemic Ventricular Tachycardia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northwestern University
Hospital at the University of Pennsylvania
Sentara Norfolk General Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

DSM

Arm Description

Treatment using DSM to guide ablation

Outcomes

Primary Outcome Measures

Incidence of serious adverse events (SAEs)

Secondary Outcome Measures

Full Information

NCT ID

NCT00558857

First Posted

November 14, 2007

Last Updated

February 1, 2019

Sponsor

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT00558857

Brief Title

Dynamic Substrate Mapping (DSM) for Ischemic VT

Acronym

DSM

Official Title

Clinical Feasibility of Using Dynamic Substrate Mapping to Guide Ablation of Ischemic Ventricular Tachycardia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Terminated

Why Stopped

Low enrollment

Study Start Date

July 2007 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott Medical Devices

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Ventricular Tachycardia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DSM

Arm Type

Active Comparator

Arm Description

Treatment using DSM to guide ablation

Intervention Type

Device

Intervention Name(s)

Dynamic Substrate Mapping-guided ablation

Intervention Description

Radiofrequency ablation

Primary Outcome Measure Information:

Title

Incidence of serious adverse events (SAEs)

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Callans, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jason Jacobson, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

Hospital at the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

Sentara Norfolk General Hospital

City

Norfolk

State/Province

Virginia

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Dynamic Substrate Mapping (DSM) for Ischemic VT

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