Monomorphic Ventricular TachycardiaSTAR-VTNCT02130765

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

A study testing Cardiac catheter ablation with ICD/CRT-D in people with Monomorphic Ventricular Tachycardia, run by Abbott Medical Devices at 38 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Monomorphic Ventricular Tachycardia
What is being tested?: Cardiac catheter ablation with ICD/CRT-D
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 38 sitesin 5 countries
Study dates: Nov 2014to 25 Jul 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 23Show fewer

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

Trial locations and contacts

38 sites in 5 countries.

Country

City, postcode or hospital

38 sites in 5 countries

United States30 sites

Emory University Hospital
Atlanta, Georgia, 30322
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins University Hospital
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Sanger Clinic
Charlotte, North Carolina, 28203
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Duke University Medical Center
Durham, North Carolina, 27710
The Methodist Hospital
Houston, Texas, 77030
Mid-America Cardiology Associates
Kansas City, Kansas, 66160
USC University Hospital
Los Angeles, California, 90033
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Loyola University Medical Center
Maywood, Illinois, 60153
Intermountain Heart Rhythm Specialist
Murray, Utah, 84107
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, 37232
New York University Hospital
New York, New York, 10016
New York University Langone Medical Center
New York, New York, 10016
Mt. Sinai Hospital
New York, New York, 10029
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19118
Mayo Clinic
Rochester, Minnesota, 55905
University of California at San Diego (UCSD) Medical Center
San Diego, California, 92103
University of California at San Francisco
San Francisco, California, 94143
University of Washington Medical Center
Seattle, Washington, 98195
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Washington University School of Medicine - Barnes Jewish Hospital
St Louis, Missouri, 63110
Mercy Hospital St. Louis
St Louis, Missouri, 63141
Staten Island University Hospital - North
Staten Island, New York, 10305
Memorial Hermann Hospital
The Woodlands, Texas, 77380
Washington Hospital Center
Washington D.C., District of Columbia, 20010

Other trials in United States

France4 sites

CHU Trousseau
Chambray-lès-Tours, Centre-Val de Loire, 37170
Clinique Protestante
Lyon, 69300
Hopital d'adulte de la Timone
Marseille, Alpes, 13005
Hôpital du Haut Lévêque
Pessac, 33604

Other trials in France

United Kingdom2 sites

Kings College Hospital
London, SE5 9RS
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE7 7DN

Other trials in United Kingdom

Australia1 site

Royale Adelaide Hospital
Adelaide, 5000

Other trials in Australia

Italy1 site

Ospedale San Raffaele
Milan, Lombardy, 20132

Other trials in Italy

About this study

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

Read the 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.

Conditions: Monomorphic Ventricular Tachycardia
Being tested: Cardiac catheter ablation with ICD/CRT-D
Keywords: Monomorphic Ventricular Tachycardia, Ischemic, Non-ischemic, Catheter Ablation
Medical subject headings: Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cardiac catheter ablation with ICD/CRT-DDevice
Cardiac ablation catheter system

Study groups in NCT02130765
Study group	Role	What they receive
Drug with ICD/CRT-D	No intervention	Implantable cardioverter defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) with routine drug therapy
Cardiac catheter ablation with ICD/CRT-D	Active comparator	Cardiac catheter ablation with ICD/CRT-D with routine drug therapy Receives: Device: Cardiac catheter ablation with ICD/CRT-D

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 12 months
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.
Measured: 30 days

Secondary outcomes (1)

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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201425 Jul 2016

First posted5 May 2014 (estimated)
Study startNov 2014
Primary completion25 Jul 2016
Study completion25 Jul 2016

Why it stopped: Terminated due to low enrollment rate.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Monomorphic Ventricular TachycardiaStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02130765
Sponsor's protocol ID: SJM-CIP-0005
Acronym: STAR-VT
Status last verified: Jan 2019
First submitted: 28 Apr 2014
Last updated: 12 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Not yet recruiting
Pivotal Study to Evaluate Catheter Ablation in Patients With Scar-Related Monomorphic Sustained VT in the Ventricular Ectopy and Reduction in Tachycardia Ablation Studies Program VERITAS SCAR VT
Scar-related Monomorphic Sustained VT
Not yet recruiting
VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Ventricular Tachycardia
Recruiting
Cryoablation for Monomorphic Ventricular Tachycardia (VTS)
Ventricular Tachycardia, Sustained, Ventricular Tachycardia, Monomorphic
Recruiting
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Ventricular Tachycardia (VT)

All Monomorphic Ventricular Tachycardia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) - G130132
ClinicalTrials.gov ID: NCT02130765
Acronym / sponsor ID: STAR-VT / SJM-CIP-0005
Conditions: Monomorphic Ventricular Tachycardia
Keywords: Monomorphic Ventricular Tachycardia, Ischemic, Non-ischemic, Catheter Ablation
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to low enrollment rate.
Enrolment: 64 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: 25 Jul 2016 (actual)
Study completion: 25 Jul 2016 (actual)
First posted: 5 May 2014 (estimated)
Results: Posted 15 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Drug with ICD/CRT-D	No intervention	–Implantable cardioverter defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) with routine drug therapy
Cardiac catheter ablation with ICD/CRT-D	Active comparator	Device: Cardiac catheter ablation with ICD/CRT-DCardiac catheter ablation with ICD/CRT-D with routine drug therapy

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (23 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cardiac catheter ablation with ICD/CRT-DCardiac ablation catheter system	Device	Cardiac catheter ablation with ICD/CRT-D

Primary outcome

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
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.

1 secondary outcome

Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit
Time frame: 12 months

Results and safety

Results posted to the registry on 15 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Randomized Subjects-Ablation	11	7
Randomized Subjects- Control	8	8
Registry Subjects	26	26
Early Withdrawal Subjects	19	19

Primary outcome: Number of Subjects Who Experienced an ICD Shock Event.

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Randomized Subjects-Ablation n = 7	Randomized Subjects- Control n = 8	Registry Subjects n = 26	Early WIthdrawal Subjects n = 19
Value	1	1	0	NA

Primary outcome: Number of Subjects Who Experienced a Select Serious Adverse Event

Time frame: 30 days. Count of participants. Unit: Participants

Measure	Randomized Subjects-Ablation n = 7	Randomized Subjects- Control n = 8	Registry Subjects n = 26	Early Withdrawal Subjects n = 19
Value	2	NA	NA	NA

Population analysed: 4 subjects randomized to treatment arm but did not receive ablation (not treated) and therefore excluded from analysis.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Enrolled Subjects	9 of 64 (14.1%)	4 of 64 (6.3%)	1 of 64
Randomized Subjects- Ablation	5 of 11 (45.5%)	1 of 11 (9.1%)	0 of 11
Randomized Subjects-Control	2 of 8 (25%)	2 of 8 (25%)	0 of 8
Registry Subjects	2 of 26 (7.7%)	1 of 26 (3.8%)	1 of 26
Early Withdrawal Subjects	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Limitations and caveats (from the sponsor): Low enrollment rates resulted in early termination. Therefore the study did not reach the target number of participants needed to achieve target power and statistically reliable results, and statistical hypothesis testing was not performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Monomorphic Ventricular Tachycardia

Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Not yet recruiting
Pivotal Study to Evaluate Catheter Ablation in Patients With Scar-Related Monomorphic Sustained VT in the Ventricular Ectopy and Reduction in Tachycardia Ablation Studies Program VERITAS SCAR VT
Scar-related Monomorphic Sustained VT
Not yet recruiting
VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Ventricular Tachycardia
Recruiting
Cryoablation for Monomorphic Ventricular Tachycardia (VTS)
Ventricular Tachycardia, Sustained, Ventricular Tachycardia, Monomorphic
Recruiting
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Ventricular Tachycardia (VT)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrea Natale, MD principal investigator

Texas Cardiac Arrhythmia Research Foundation

Francis Marchlinski, MD principal investigator

University of Pennsylvania

38 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac catheter ablation with ICD/CRT-D in people with Monomorphic Ventricular Tachycardia, run by Abbott Medical Devices at 38 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, France, United Kingdom, Australia, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Who Experienced an ICD Shock Event. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02130765.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.