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Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT)

Primary Purpose

Monomorphic Ventricular Tachycardia

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cardiac catheter ablation with ICD/CRT-D
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Monomorphic Ventricular Tachycardia focused on measuring Monomorphic Ventricular Tachycardia, Ischemic, Non-ischemic, Catheter Ablation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is receiving a new St.Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) or SJM Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implant, which has study required programing capabilities and is appropriate for remote monitoring. Subjects who have received the ICD / CRT-D up to 90 days prior to enrollment are also eligible.
  • Patient who has a high risk of ICD shock as shown by at least one documented Monomorphic VT (MMVT)** by one or more of the following:

Spontaneous MMVT or Inducible MMVT during electrophysiology (EP) Study or Inducible MMVT during Non-Invasive Programmed Stimulation (NIPS) Study

  • 18 to 75 years of age

  • Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent approved by the Institutional Review Board.

    • Note Pleiomorphic ventricular tachycardia (VT) (multiple MMVT morphologies) is acceptable but polymorphic VT or ventricular fibrillation (VF) is not.

Exclusion Criteria:

  • Any history of stroke
  • S-T elevation myocardial infarction (MI) or previous cardiac surgery within 60 days prior to enrollment
  • Patient is pregnant or nursing
  • Patient has New York Heart Association (NYHA) class IV heart failure
  • Patient has incessant ventricular tachycardia (VT) necessitating immediate treatment (Patients with Incessant VT have continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥3) hours)
  • Patient has VT/VF thought to be from channelopathies
  • Limited life expectancy (less than one year) according to Investigator
  • Patient has current class IV angina
  • Recent coronary artery bypass graft (CABG < 60 days) or percutaneous coronary intervention (PCI < 30 days)
  • Patient is currently participating in another investigational drug or device study
  • Patient is unable or unwilling to cooperate with the study procedures
  • Known presence of intracardiac thrombi (i.e., positive Transesophageal Echocardiogram (TEE) for LA or LV clot). TEE is required for history of left atrium (LA) or left ventricle (LV) clot and recommended for history of atrial fibrillation (AF) with CHADS > 1
  • Prosthetic mitral or aortic valve
  • Mitral or aortic valvular heart disease requiring immediate surgical intervention
  • Major contraindication to anticoagulation therapy or coagulation disorder
  • Left Ventricular Ejection Fraction < 15%
  • Patient has had a previous ablation procedure for ventricular tachycardia (VT), excluding remote (> 3 months) outflow tract tachycardia
  • Patient has glomerular filtration rate (GFR) < 30 mL/min/1.73m2 within the past 3 months
  • Patient has peripheral vascular disease that precludes LV access
  • Patient has a premature ventricular contraction (PVC) or VT induced cardiomyopathy that is expected to resolve with ablation and will not require an ICD
  • Patient has reversible cause of VT
  • Use of left ventricular assist device (LVAD) or Tandem Heart devices (Impella and Balloon pumps are acceptable)
  • There is a strong clinical reason to believe that, in the opinion of the investigator, the patient only has septal scar that is deep

Sites / Locations

  • University of Alabama at Birmingham
  • USC University Hospital
  • Ronald Reagan UCLA Medical Center
  • University of California at San Diego (UCSD) Medical Center
  • University of California at San Francisco
  • Washington Hospital Center
  • Emory University Hospital
  • Loyola University Medical Center
  • Mid-America Cardiology Associates
  • University of Maryland Medical Center
  • Johns Hopkins University Hospital
  • Massachusetts General Hospital
  • Mayo Clinic
  • Barnes-Jewish Hospital
  • Washington University School of Medicine - Barnes Jewish Hospital
  • Mercy Hospital St. Louis
  • New York University Hospital
  • New York University Langone Medical Center
  • Mt. Sinai Hospital
  • Staten Island University Hospital - North
  • Sanger Clinic
  • Duke University Medical Center
  • University Hospitals of Cleveland
  • Hospital of the University of Pennsylvania
  • Vanderbilt Heart and Vascular Institute
  • Texas Cardiac Arrhythmia Research Foundation
  • The Methodist Hospital
  • Memorial Hermann Hospital
  • Intermountain Heart Rhythm Specialist
  • University of Washington Medical Center
  • Royale Adelaide Hospital
  • Hopital d'adulte de la Timone
  • CHU Trousseau
  • Clinique Protestante
  • Hôpital du Haut Lévêque
  • Ospedale San Raffaele
  • Freeman Hospital
  • Kings College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Drug with ICD/CRT-D

Cardiac catheter ablation with ICD/CRT-D

Arm Description

Implantable cardioverter defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) with routine drug therapy

Cardiac catheter ablation with ICD/CRT-D with routine drug therapy

Outcomes

Primary Outcome Measures

Number of Subjects Who Experienced an ICD Shock Event.
Primary Effectiveness endpoint: Number reported is number of subjects who experienced an ICD shock event (including both appropriate and inappropriate) through 12 month follow up
Number of Subjects Who Experienced a Select Serious Adverse Event
Primary Safety Endpoint: Number of subjects who experience a select serious adverse events within the 30 day follow up. Those events are anticipated, associated with catheter ablation, and are cardiovascular, pulmonary, or peripheral vascular in nature, as listed in the Primary Safety Events List.

Secondary Outcome Measures

Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit
Number of subjects that had a CV hospitalization or CV-related ER visit through 12 month follow up.

Full Information

First Posted
April 28, 2014
Last Updated
January 28, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02130765
Brief Title
Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia
Acronym
STAR-VT
Official Title
Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) - G130132
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to low enrollment rate.
Study Start Date
November 2014 (undefined)
Primary Completion Date
July 25, 2016 (Actual)
Study Completion Date
July 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia [MMVT] (both ischemic and non-ischemic) while maintaining an acceptable safety profile.
Detailed Description
Approximately 50 centers in the United States (US) will participate in the study. Additional centers outside the US may be considered, as necessary. The anticipated enrollment duration is 48-60 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monomorphic Ventricular Tachycardia
Keywords
Monomorphic Ventricular Tachycardia, Ischemic, Non-ischemic, Catheter Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug with ICD/CRT-D
Arm Type
No Intervention
Arm Description
Implantable cardioverter defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) with routine drug therapy
Arm Title
Cardiac catheter ablation with ICD/CRT-D
Arm Type
Active Comparator
Arm Description
Cardiac catheter ablation with ICD/CRT-D with routine drug therapy
Intervention Type
Device
Intervention Name(s)
Cardiac catheter ablation with ICD/CRT-D
Intervention Description
Cardiac ablation catheter system
Primary Outcome Measure Information:
Title
Number of Subjects Who Experienced an ICD Shock Event.
Description
Primary Effectiveness endpoint: Number reported is number of subjects who experienced an ICD shock event (including both appropriate and inappropriate) through 12 month follow up
Time Frame
12 months
Title
Number of Subjects Who Experienced a Select Serious Adverse Event
Description
Primary Safety Endpoint: Number of subjects who experience a select serious adverse events within the 30 day follow up. Those events are anticipated, associated with catheter ablation, and are cardiovascular, pulmonary, or peripheral vascular in nature, as listed in the Primary Safety Events List.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit
Description
Number of subjects that had a CV hospitalization or CV-related ER visit through 12 month follow up.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is receiving a new St.Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) or SJM Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implant, which has study required programing capabilities and is appropriate for remote monitoring. Subjects who have received the ICD / CRT-D up to 90 days prior to enrollment are also eligible. Patient who has a high risk of ICD shock as shown by at least one documented Monomorphic VT (MMVT)** by one or more of the following: Spontaneous MMVT or Inducible MMVT during electrophysiology (EP) Study or Inducible MMVT during Non-Invasive Programmed Stimulation (NIPS) Study 18 to 75 years of age Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent approved by the Institutional Review Board. Note Pleiomorphic ventricular tachycardia (VT) (multiple MMVT morphologies) is acceptable but polymorphic VT or ventricular fibrillation (VF) is not. Exclusion Criteria: Any history of stroke S-T elevation myocardial infarction (MI) or previous cardiac surgery within 60 days prior to enrollment Patient is pregnant or nursing Patient has New York Heart Association (NYHA) class IV heart failure Patient has incessant ventricular tachycardia (VT) necessitating immediate treatment (Patients with Incessant VT have continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥3) hours) Patient has VT/VF thought to be from channelopathies Limited life expectancy (less than one year) according to Investigator Patient has current class IV angina Recent coronary artery bypass graft (CABG < 60 days) or percutaneous coronary intervention (PCI < 30 days) Patient is currently participating in another investigational drug or device study Patient is unable or unwilling to cooperate with the study procedures Known presence of intracardiac thrombi (i.e., positive Transesophageal Echocardiogram (TEE) for LA or LV clot). TEE is required for history of left atrium (LA) or left ventricle (LV) clot and recommended for history of atrial fibrillation (AF) with CHADS > 1 Prosthetic mitral or aortic valve Mitral or aortic valvular heart disease requiring immediate surgical intervention Major contraindication to anticoagulation therapy or coagulation disorder Left Ventricular Ejection Fraction < 15% Patient has had a previous ablation procedure for ventricular tachycardia (VT), excluding remote (> 3 months) outflow tract tachycardia Patient has glomerular filtration rate (GFR) < 30 mL/min/1.73m2 within the past 3 months Patient has peripheral vascular disease that precludes LV access Patient has a premature ventricular contraction (PVC) or VT induced cardiomyopathy that is expected to resolve with ablation and will not require an ICD Patient has reversible cause of VT Use of left ventricular assist device (LVAD) or Tandem Heart devices (Impella and Balloon pumps are acceptable) There is a strong clinical reason to believe that, in the opinion of the investigator, the patient only has septal scar that is deep
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francis Marchlinski, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
USC University Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California at San Diego (UCSD) Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Mid-America Cardiology Associates
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine - Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
New York University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mt. Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Staten Island University Hospital - North
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Sanger Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19118
Country
United States
Facility Name
Vanderbilt Heart and Vascular Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Memorial Hermann Hospital
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Intermountain Heart Rhythm Specialist
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Royale Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Hopital d'adulte de la Timone
City
Marseille
State/Province
Alpes
ZIP/Postal Code
13005
Country
France
Facility Name
CHU Trousseau
City
Chambray-lès-Tours
State/Province
Centre
ZIP/Postal Code
37170
Country
France
Facility Name
Clinique Protestante
City
Lyon
ZIP/Postal Code
69300
Country
France
Facility Name
Hôpital du Haut Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Ospedale San Raffaele
City
Milano
State/Province
Lombardy
ZIP/Postal Code
20132
Country
Italy
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia

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