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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02130765




Registration number
NCT02130765
Ethics application status
Date submitted
28/04/2014
Date registered
5/05/2014
Date last updated
12/02/2019

Titles & IDs
Public title
Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia
Scientific title
Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) - G130132
Secondary ID [1] 0 0
SJM-CIP-0005
Universal Trial Number (UTN)
Trial acronym
STAR-VT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Monomorphic Ventricular Tachycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Cardiac catheter ablation with ICD/CRT-D

No Intervention: Drug with ICD/CRT-D - Implantable cardioverter defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) with routine drug therapy

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


Treatment: Devices: Cardiac catheter ablation with ICD/CRT-D
Cardiac ablation catheter system

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royale Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Georgia
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Illinois
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Kansas
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United States of America
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Maryland
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United States of America
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Massachusetts
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Minnesota
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Missouri
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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United States of America
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Texas
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Utah
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United States of America
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Washington
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France
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Alpes
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France
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Centre
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France
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Lyon
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France
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Pessac
Country [23] 0 0
Italy
State/province [23] 0 0
Lombardy
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United Kingdom
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Tyne And Wear
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United Kingdom
State/province [25] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02130765
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrea Natale, MD
Address 0 0
Texas Cardiac Arrhythmia Research Foundation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02130765