Dynamic Substrate Mapping (DSM) for Ischemic VT

Phase 1

Terminated

• Conditions: Ischemic Ventricular Tachycardia
• Interventions: Device: Dynamic Substrate Mapping-guided ablation

• Registration Number: NCT00558857
• Lead Sponsor: Abbott Medical Devices

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 available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-11-14
• Study First Submitted QC: 2007-11-14
• Study First Posted: 2007-11-15
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DSM	Dynamic Substrate Mapping-guided ablation	Treatment using DSM to guide ablation

Primary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (SAEs)	30 days

Trial Locations

Locations (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