Dynamic Substrate Mapping (DSM) for Ischemic VT

Ischemic Ventricular Tachycardia Clinical Trial

— DSM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00558857
• Other study ID #: 065.5
• Status: Terminated
• Phase: Phase 1
• Start date: July 2007
• Est. completion date: April 2009

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular

Intervention

Device:
• Dynamic Substrate Mapping-guided ablation
Radiofrequency ablation

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Hospital at the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse events (SAEs)		30 days