Ventricular TachycardiaLESS-VTNCT03490201
FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study
A study testing Market Approved RF Ablation System and FlexAbility SE Ablation Catheter in people with Ventricular Tachycardia, run by Abbott Medical Devices at 32 sites in 8 countries.
Trial summary
This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Market Approved RF Ablation System and FlexAbility SE Ablation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- 32 sitesin 8 countries
- Study dates
- 1 Jun 2018to 11 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Structural heart disease (ischemic or non-ischemic) with one of the following:
- Confirmed diagnosis via echocardiography and/or cardiac CT/MRI [computed tomography/magnetic resonance imaging], or
- Left ventricular ejection fraction (EF) <40% (documented within the last 6 months via echocardiography, or
- Arrhythmogenic RV [right ventricular] cardiomyopathy/dysplasia (per 2010 ARVC/D [arrhythmogenic right ventricular cardiomyopathy/dysplasia] Task Force Criteria).27
- At least one documented episode of sustained MMVT by either EGM [cardiac electrogram] or ECG [electrocardiogram] in the 6 months prior to enrollment
- Implanted with a market released ICD [implantable cardioverter-defibrillator] or CRT-D [cardiac resynchronization therapy-defibrillator] for at least 30 days prior to index ablation procedure
Show all 10Show fewer
- Refractory (i.e. not effective, not tolerated or not desired) to at least one anti-arrhythmic medication (either amiodarone or sotalol) for treatment of MMVT
- At least 18 years of age
- Informed of the nature of the study, agreed to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical study site.
- Able and willing to comply with all study requirements
Who cannot join
- Implanted with a subcutaneous ICD
- Implanted with a ventricular assist device (VAD) (e.g. TandemHeart)
- Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO)
- Presence of intracardiac thrombus verified via computer tomography (CT), magnetic resonance imaging (MRI), transesophageal echocardiogram (TEE), or transthoracic echocardiogram (TTE) within 48 hours prior to the index ablation procedure or intra-procedure intracardiac echocardiography (ICE)
- o For subjects with a history of AF [atrial fibrillation], this verification must be done via TEE or ICE
- ST elevation myocardial infarction (MI) within 60 days prior to index ablation procedure
Show all 25Show fewer
- Previous cardiac surgery (e.g. ventriculotomy, atriotomy, coronary artery bypass graft), within 60 days prior to index ablation procedure
- Percutaneous coronary intervention (PCI) within 30 days prior to index ablation procedure
- Idiopathic VT
- Incessant VT (continuous sustained VT that promptly recurs despite repeated intervention for termination over ≥3 hours) necessitating immediate treatment or requiring hemodynamic support prior to the ablation procedure
- VT/VF [ventricular tachycardia/ventricular fibrillation] thought to be from channelopathies
- Reversible cause of VT
- Severe aortic stenosis or flail mitral valve
- Mechanical mitral and aortic valve
- History of stroke with modified Rankin scale > 3 (See Appendix C)
- Unstable angina
- Chronic NYHA [New York Heart Association] Class IV heart failure
- Ejection fraction < 15%
- Thrombocytopenia (defined as platelet count <80,000) or coagulopathy
- Contraindication to systemic anticoagulation (i.e. heparin, warfarin, or a direct thrombin inhibitor)
- Women who are pregnant or nursing
- Active uncontrolled infection
- Other anatomic or co morbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow up requirements, or impact the scientific soundness of the study results
- Enrolled in an investigational study evaluating another device or drug that would confound the results of this study
- Have a life expectancy of less than 12 months due to any condition.
Trial locations and contacts
32 sites in 8 countries.
32 sites in 8 countries
United States23 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30322
University of Colorado Hospital
Aurora, Colorado, 80045
Texas Cardiac Arrhythmia
Austin, Texas, 78705
Johns Hopkins University Hospital
Baltimore, Maryland, 21287
Affinity Cardiovascular Specialists, LLC
Birmingham, Alabama, 35243
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35249
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
Broward General Medical Center
Fort Lauderdale, Florida, 33316
Memorial Regional Hospital
Hollywood, Florida, 33020
Texas Heart Institute
Houston, Texas, 77030
USC University Hospital
Los Angeles, California, 90033
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
VA Medical Center Minneapolis
Minneapolis, Minnesota, 55417
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, 37240
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
WakeMed Hospital
Raleigh, North Carolina, 27610
Mayo Clinic
Rochester, Minnesota, 55905
University of California at San Diego (UCSD) Medical Center
San Diego, California, 92103
University of Washington
Seattle, Washington, 98195
University of South Florida
Tampa, Florida, 33606
Memorial Hermann Hospital
The Woodlands, Texas, 77380
Czechia2 sites
IKEM
Prague, Central Bohemia, 14021
Nemocnice Na Homolce
Prague, 15030
Italy2 sites
Ospedale San Raffaele
Milan, 20132
Centro Cardiologico Monzino
Milan, 20138
About this study
Official title: FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study
This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.
Read the detailed description
This is a regulated, prospective, multi-center trial designed to evaluate the safety and effectiveness of the FlexAbility[TM] Ablation Catheter, Sensor Enabled[TM] (FlexAbility SE) catheter to obtain an indication to treat monomorphic ventricular tachycardia (MMVT) in the United States of America (US). The clinical trial has two cohorts: one is a randomized ischemic cardiomyopathy (ICM) cohort and the second is a concurrent single-arm non-ischemic cardiomyopathy (NICM) cohort. Four hundred ten (410) subjects with drug refractory sustained MMVT and ICM and 182 subjects with drug refractory sustained MMVT and NICM will be enrolled at up to 35 centers worldwide. Study subjects who have drug refractory sustained MMVT and ICM will be randomized 1:1 to treatment with the FlexAbility SE catheter ablation system in the Treatment group, or the ThermoCool, ThermoCool NaviStar, or ThermoCool SmartTouch Ablation Catheter from Biosense Webster in the Control group. Since at study start there was no approved device for VT ablation in patients with NICM to use as a comparator, subjects who have drug refractory MMVT and NICM will be treated with the FlexAbility SE catheter ablation system only.
- Conditions
- Ventricular Tachycardia
- Being tested
- Market Approved RF Ablation System, FlexAbility SE Ablation Catheter
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Market Approved RF Ablation SystemDevice
Subjects receive ablation using an FDA approved radiofrequency (RF) ablation system.
FlexAbility SE Ablation CatheterDevice
Subjects receive ablation treatment using an ablation system that is not FDA approved.
| Study group | Role | What they receive |
|---|---|---|
| Randomized - Control | Active comparator | Subjects with ICM and randomized to the Control group will undergo mapping and substrate-based ablation for the treatment of ventricular tachycardia with any of the protocol-specified commercially available ablation catheters indicated for patients with ICM. A protocol-specified commercially available mapping system will be used in conjunction with the control catheter in the ablation procedure. Subjects will be followed for 12 months post-procedure. Receives: Device: Market Approved RF Ablation System |
| Randomized - Treatment | Active comparator | Subjects with ICM and randomized to the Treatment group will undergo mapping and substrate-based ablation for the treatment of ventricular tachycardia with the investigational FlexAbility SE Catheter. The Ampere Generator, Cool Point Irrigation Pump and the EnSite Precision Cardiac Mapping System or EnSite X EP System will be used in conjunction with the FlexAbility SE catheter in the ablation procedure. Subjects will be followed for 12 months post-procedure. Receives: Device: FlexAbility SE Ablation Catheter |
| Non-randomized - Treatment | Experimental | Subjects with NICM will undergo mapping and substrate-based ablation for the treatment of ventricular tachycardia with the investigational FlexAbility SE Catheter. The Ampere Generator, Cool Point Irrigation Pump and the EnSite Precision Cardiac Mapping System or EnSite X EP System will be used in conjunction with the FlexAbility SE catheter in the ablation procedure. Subjects will be followed for 12 months post-procedure. Receives: Device: FlexAbility SE Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complications
The primary safety endpoint is a composite of cardiovascular-related and procedure-related major complications through 7 days post index ablation procedure.
Measured: 7 days
Freedom from recurrence of VT
The primary effectiveness endpoint is freedom from recurrent sustained MMVT at 6 months and a new or increased dose Class I or III antiarrhythmic drugs (AAD) at 6 months following the index ablation procedure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start1 Jun 2018
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Pivotal medical device study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Kammer, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490201
- Sponsor's protocol ID
- SJM-CIP-10138
- Acronym
- LESS-VT
- Status last verified
- Jan 2025
- First submitted
- 28 Aug 2017
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study
- ClinicalTrials.gov ID
- NCT03490201
- Acronym / sponsor ID
- LESS-VT / SJM-CIP-10138
- Conditions
- Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.
Detailed description
This is a regulated, prospective, multi-center trial designed to evaluate the safety and effectiveness of the FlexAbility[TM] Ablation Catheter, Sensor Enabled[TM] (FlexAbility SE) catheter to obtain an indication to treat monomorphic ventricular tachycardia (MMVT) in the United States of America (US). The clinical trial has two cohorts: one is a randomized ischemic cardiomyopathy (ICM) cohort and the second is a concurrent single-arm non-ischemic cardiomyopathy (NICM) cohort. Four hundred ten (410) subjects with drug refractory sustained MMVT and ICM and 182 subjects with drug refractory sustained MMVT and NICM will be enrolled at up to 35 centers worldwide. Study subjects who have drug refractory sustained MMVT and ICM will be randomized 1:1 to treatment with the FlexAbility SE catheter ablation system in the Treatment group, or the ThermoCool, ThermoCool NaviStar, or ThermoCool SmartTouch Ablation Catheter from Biosense Webster in the Control group. Since at study start there was no approved device for VT ablation in patients with NICM to use as a comparator, subjects who have drug refractory MMVT and NICM will be treated with the FlexAbility SE catheter ablation system only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Pivotal medical device study
| Arm | Type | Receives |
|---|---|---|
| Randomized - Control | Active comparator | Device: Market Approved RF Ablation SystemSubjects with ICM and randomized to the Control group will undergo mapping and substrate-based ablation for the treatment of ventricular tachycardia with any of the protocol-specified commercially available ablation catheters indicated for patients with ICM. A protocol-specified commercially available mapping system will be used in conjunction with the control catheter in the ablation procedure. Subjects will be followed for 12 months post-procedure. |
| Randomized - Treatment | Active comparator | Device: FlexAbility SE Ablation CatheterSubjects with ICM and randomized to the Treatment group will undergo mapping and substrate-based ablation for the treatment of ventricular tachycardia with the investigational FlexAbility SE Catheter. The Ampere Generator, Cool Point Irrigation Pump and the EnSite Precision Cardiac Mapping System or EnSite X EP System will be used in conjunction with the FlexAbility SE catheter in the ablation procedure. Subjects will be followed for 12 months post-procedure. |
| Non-randomized - Treatment | Experimental | Device: FlexAbility SE Ablation CatheterSubjects with NICM will undergo mapping and substrate-based ablation for the treatment of ventricular tachycardia with the investigational FlexAbility SE Catheter. The Ampere Generator, Cool Point Irrigation Pump and the EnSite Precision Cardiac Mapping System or EnSite X EP System will be used in conjunction with the FlexAbility SE catheter in the ablation procedure. Subjects will be followed for 12 months post-procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Structural heart disease (ischemic or non-ischemic) with one of the following:
- At least one documented episode of sustained MMVT by either EGM [cardiac electrogram] or ECG [electrocardiogram] in the 6 months prior to enrollment
- Implanted with a market released ICD [implantable cardioverter-defibrillator] or CRT-D [cardiac resynchronization therapy-defibrillator] for at least 30 days prior to index ablation procedure
- Refractory (i.e. not effective, not tolerated or not desired) to at least one anti-arrhythmic medication (either amiodarone or sotalol) for treatment of MMVT
- At least 18 years of age
Key exclusion criteria (25 listed)
- Implanted with a subcutaneous ICD
- Implanted with a ventricular assist device (VAD) (e.g. TandemHeart)
- Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO)
- Presence of intracardiac thrombus verified via computer tomography (CT), magnetic resonance imaging (MRI), transesophageal echocardiogram (TEE), or transthoracic echocardiogram (TTE) within 48 hours prior to the index ablation procedure or intra-procedure intracardiac echocardiography (ICE)
- o For subjects with a history of AF [atrial fibrillation], this verification must be done via TEE or ICE
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 |
|---|---|---|
| Market Approved RF Ablation SystemSubjects receive ablation using an FDA approved radiofrequency (RF) ablation system. | Device | Randomized - Control |
| FlexAbility SE Ablation CatheterSubjects receive ablation treatment using an ablation system that is not FDA approved. | Device | Non-randomized - Treatment, Randomized - Treatment |
Primary outcome
Rate of complications
Time frame: 7 days
The primary safety endpoint is a composite of cardiovascular-related and procedure-related major complications through 7 days post index ablation procedure.
Freedom from recurrence of VT
Time frame: 6 months
The primary effectiveness endpoint is freedom from recurrent sustained MMVT at 6 months and a new or increased dose Class I or III antiarrhythmic drugs (AAD) at 6 months following the index ablation procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
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VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
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Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
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SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
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.
Sarah Kammer study director
Abbott
32 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Market Approved RF Ablation System and FlexAbility SE Ablation Catheter in people with Ventricular Tachycardia, run by Abbott Medical Devices at 32 sites in 8 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 10 inclusion and 25 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: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Czechia, Italy, Australia, France and 3 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of complications (time frame: 7 days). 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?
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 8 Jan 2025.