Dynamic Substrate Mapping (DSM) for Ischemic VT

Abbott

Status and phase

Terminated

Phase 1

Conditions

Ischemic Ventricular Tachycardia

Treatments

Device: Dynamic Substrate Mapping-guided ablation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00558857

065.5

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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