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Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia (STRATUM VT)

Primary Purpose

Ventricular Tachycardia, Catheter Ablation, Tachycardia, Ventricular

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
catheter-based ablation
Sponsored by
Vivek Reddy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ventricular Tachycardia focused on measuring ventricular tachycardia, catheter ablation, VT

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 to 90 years.
  • History of coronary artery disease.
  • Presence of, or planned for, an ICD prior to discharge.
  • Presentation for management of ICD shock/ATP therapy or monomorphic ventricular tachycardia.

Exclusion Criteria:

  • Ventricular arrhythmia not thought to be due to CAD.
  • Unstable angina
  • CVA within 30 days.
  • Protruding left ventricular thrombus or critical aortic stenosis on pre-ablation echocardiography
  • Pregnancy
  • Any condition resulting in an absolute contraindication to anticoagulation
  • Inability to follow-up at ICD clinic.
  • Inability to give informed consent.
  • Non-inducible for sustained monomorphic ventricular tachycardia.
  • Prior substrate guided ablation.
  • Definite need for epicardial ablation, as determined by the primary operator.

Sites / Locations

  • University of Alabama - Birmingham
  • Loyola University
  • Brigham & Women's Hospital
  • Beth Israel-Deaconess Medical Center
  • Icahn School of Medicine at Mount Sinai
  • University of Pennsylvania
  • Hospital Regional Sao Jose
  • Southlake Regional Health Center
  • Homolka Hospital
  • San Raffaele Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

catheter-based ablation

Arm Description

catheter ablation - a medical procedure used to treat some types of arrhythmia

Outcomes

Primary Outcome Measures

Catheter Ablation
The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia

Secondary Outcome Measures

ICD Interrogation
Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline.
Procedural Safety
2) Procedural safety as defined by the number of complication within 1week associated with the procedure.
Signal-Average ECG
Relationship between change in pre/post saECG and success of the step-wise ablation strategy

Full Information

First Posted
February 13, 2012
Last Updated
December 27, 2019
Sponsor
Vivek Reddy
Collaborators
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01546207
Brief Title
Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia
Acronym
STRATUM VT
Official Title
Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
September 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vivek Reddy
Collaborators
Biosense Webster, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this trial is to test the impact of a step-wise approach for catheter ablation of recurrent ventricular tachycardia, (irregular heart rhythms that originate in the bottom chambers of the heart), in patients with a previous heart attack for whom catheter ablation is clinically indicated.
Detailed Description
Sudden cardiac death due to VT (ventricular tachycardia) or VF (ventricular fibrillation) occurs at an estimated rate of 300,000 events per year in United States, accounting for 5.6% of annual mortality22. A significant proportion of patients treated with ICDs (implantable defibrillators) will receive shocks due to recurrent VT, resulting in increased mortality8. As a result, catheter-based ablation has emerged as an effective treatment for recurrent VT. However, no study has assessed the impact of a step-wise approach on the outcome of catheter ablation of VT. The investigators propose a prospective, multicenter, non-randomized, single-arm trial to evaluate the impact of a step-wise approach to catheter ablation on ventricular tachycardia recurrence. Given the increasing use of catheter ablation in patients with recurrent ventricular tachycardia, this study will answer a critical question regarding the impact of a step-wise approach on the inducibility of VT at the end of the procedure and clinical recurrences of ventricular arrhythmias at 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Catheter Ablation, Tachycardia, Ventricular
Keywords
ventricular tachycardia, catheter ablation, VT

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
catheter-based ablation
Arm Type
Other
Arm Description
catheter ablation - a medical procedure used to treat some types of arrhythmia
Intervention Type
Procedure
Intervention Name(s)
catheter-based ablation
Intervention Description
specific electrophysiological and mapping techniques of activation and entrainment mapping during ongoing VT. Substrate mapping and ablation (substrate modification.) catheter ablation - a medical procedure used to treat some types of arrhythmia
Primary Outcome Measure Information:
Title
Catheter Ablation
Description
The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia
Time Frame
at time of catheter ablation procedure (intraoperative)
Secondary Outcome Measure Information:
Title
ICD Interrogation
Description
Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline.
Time Frame
baseline and 6 months follow-up
Title
Procedural Safety
Description
2) Procedural safety as defined by the number of complication within 1week associated with the procedure.
Time Frame
1 week post-op
Title
Signal-Average ECG
Description
Relationship between change in pre/post saECG and success of the step-wise ablation strategy
Time Frame
baseline and post-op day one after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 90 years. History of coronary artery disease. Presence of, or planned for, an ICD prior to discharge. Presentation for management of ICD shock/ATP therapy or monomorphic ventricular tachycardia. Exclusion Criteria: Ventricular arrhythmia not thought to be due to CAD. Unstable angina CVA within 30 days. Protruding left ventricular thrombus or critical aortic stenosis on pre-ablation echocardiography Pregnancy Any condition resulting in an absolute contraindication to anticoagulation Inability to follow-up at ICD clinic. Inability to give informed consent. Non-inducible for sustained monomorphic ventricular tachycardia. Prior substrate guided ablation. Definite need for epicardial ablation, as determined by the primary operator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek Reddy, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Loyola University
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel-Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Hospital Regional Sao Jose
City
Santa Catarina
Country
Brazil
Facility Name
Southlake Regional Health Center
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Homolka Hospital
City
Prague
Country
Czechia
Facility Name
San Raffaele Hospital
City
Milan
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia

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