Dynamic Substrate Mapping (DSM) for Ischemic VT | NCT00558857

Studies
Dynamic Substrate Mapping (DSM) for Ischemic VT

NCT00558857

Sponsor

Abbott Medical Devices

Status

Terminated

Last Update Posted

Feb 4, 2019Actual

Enrollment

5Actual

Phase

Phase 1

Conditions

Ischemic Ventricular Tachycardia

Interventions

Dynamic Substrate Mapping-guided ablation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low enrollment

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Nov 14, 2007

First Submission Date that Met QC Criteria

Nov 14, 2007

First Posted Date

Nov 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DSM	Active Comparator	Treatment using DSM to guide ablation	Device: Dynamic Substrate Mapping-guided ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dynamic Substrate Mapping-guided ablation	Device	Radiofrequency ablation	DSM

Measure	Description	Time Frame
Incidence of serious adverse events (SAEs)		30 days

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Callans, MD	University of Pennsylvania	Principal Investigator
Jason Jacobson, MD	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University		Chicago	Illinois		United States
Hospital at the University of Pennsylvania