NCT00558857

TerminatedPhase 1

Dynamic Substrate Mapping (DSM) for Ischemic VT

Abbott Medical Devices Source

Abbott Medical Devices

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

065.5

Study Type

interventional

Actual enrollment (reported)

5

Locations

1 country

Sites

3

Timeline

Study Start

July 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2009

Actual (reported)

Study Completion

April 2009

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 5 participants
Study completion date: April 2009
Actual (reported)
Listed locations: 1 countries · 3 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2007
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 14, 2007
Actual (reported)
First Posted
November 15, 2007
Actual (reported)
Primary Completion
April 2009
Actual (reported)
Study Completion
April 2009
Actual (reported)

Last Updated: February 4, 2019
Status Verified: February 2019
Last Update Submitted: February 1, 2019

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 ablationDevice

Radiofrequency ablation

DSM

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Abbott Medical Devices
Industrylead

Study Sites (3)

Northwestern University

Chicago, Illinois, United States

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Study Officials

David Callans, MD
University of Pennsylvania
PRINCIPAL INVESTIGATOR
Jason Jacobson, MD
Northwestern University
PRINCIPAL INVESTIGATOR

Enrollment

5 participants (actual enrollment reported by the registry).

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 2007

Date type not reported

This date has not been verified as actual or estimated.

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

Contact the study team to confirm eligibility.

Primary Completion

April 2009

Actual (reported)

Study Completion

April 2009

Actual (reported)

Last Updated

February 4, 2019

Record last verified: 2019-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00558857
Data provider: ClinicalTrials.gov
Source updated: 2019-02-04
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:50 UTC

Locations

US(3)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

DSM

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations