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

January 28, 2019 updated by: Abbott Medical Devices

Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) - G130132

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Royale Adelaide Hospital
  • France
      • Lyon, France, 69300
        • Clinique Protestante
      • Pessac, France, 33604
        • Hôpital du Haut Lévêque
    • Alpes
      • Marseille, Alpes, France, 13005
        • Hopital d'adulte de la Timone
    • Centre
      • Chambray-lès-Tours, Centre, France, 37170
        • CHU Trousseau
  • Italy
    • Lombardy
      • Milano, Lombardy, Italy, 20132
        • Ospedale San Raffaele
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital
    • Tyne And Wear
      • Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
        • Freeman Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90033
        • USC University Hospital
      • San Diego, California, United States, 92103
        • University of California at San Diego (UCSD) Medical Center
      • San Francisco, California, United States, 94143
        • University of California at San Francisco
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Mid-America Cardiology Associates
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital St. Louis
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine - Barnes Jewish Hospital
    • New York
      • New York, New York, United States, 10016
        • New York University Hospital
      • New York, New York, United States, 10016
        • New York University Langone Medical Center
      • New York, New York, United States, 10029
        • Mt. Sinai Hospital
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital - North
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Sanger Clinic
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19118
        • Hospital of the University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Heart and Vascular Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • The Woodlands, Texas, United States, 77380
        • Memorial Hermann Hospital
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Heart Rhythm Specialist
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Device: Cardiac catheter ablation with ICD/CRT-D
Cardiac ablation catheter system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Experienced an ICD Shock Event.
Time Frame: 12 months
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
12 months
Number of Subjects Who Experienced a Select Serious Adverse Event
Time Frame: 30 days
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit
Time Frame: 12 months
Number of subjects that had a CV hospitalization or CV-related ER visit through 12 month follow up.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francis Marchlinski, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 25, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJM-CIP-0005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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