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FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study (LESS-VT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490201
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : December 7, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE August 28, 2017
First Posted Date  ICMJE April 6, 2018
Last Update Posted Date December 7, 2022
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2019)
  • 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 AAD at 6 months following the index ablation procedure.
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2018)
  • Rate of complications [ Time Frame: 30 days ]
    The primary safety endpoint is a composite of cardiovascular-related and procedure-related major complications through 30 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 AAD at 6 months following the index ablation procedure.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study
Official Title  ICMJE FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study
Brief 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 when antiarrhythmic drugs are not tolerated or desired.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pivotal medical device study
Masking: Single (Participant)
Masking Description:
Subjects are blinded to the randomization assignment.
Primary Purpose: Treatment
Condition  ICMJE Ventricular Tachycardia
Intervention  ICMJE
  • Device: Market Approved RF Ablation System
    Subjects receive ablation using an FDA approved ablation system.
  • Device: FlexAbility SE Ablation Catheter
    Subjects receive ablation treatment using an ablation system that is not FDA approved.
Study Arms  ICMJE
  • Active Comparator: Randomized - Control
    Intervention: Device: Market Approved RF Ablation System
  • Active Comparator: Randomized - Treatment
    Intervention: Device: FlexAbility SE Ablation Catheter
  • Experimental: Non-randomized - Treatment
    Intervention: Device: FlexAbility SE Ablation Catheter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2018)		 592
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2018)		 623
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Structural heart disease (ischemic or non-ischemic) with one of the following:

    • Confirmed diagnosis via echocardiography and/or cardiac CT/MRI, or
    • Left ventricular ejection fraction (EF) <40% (documented within the last 6 months via echocardiography, or
    • Arrhythmogenic RV cardiomyopathy/dysplasia (per 2010 ARVC/D Task Force Criteria).27
  • At least one documented episode of sustained MMVT by either EGM or ECG in the 6 months prior to enrollment
  • Implanted with a market released ICD or CRT-D 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
  • 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

Exclusion Criteria:

  • 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, this verification must be done via TEE or ICE

  • ST elevation myocardial infarction (MI) within 60 days prior to index ablation procedure
  • 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 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jessica Arrett +16123808445 jessica.arrett@abbott.com
Contact: Amber Miller, PhD 651-756-2885 amber.miller@abbott.com
Listed Location Countries  ICMJE Czechia,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03490201
Other Study ID Numbers  ICMJE SJM-CIP-10138
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Abbott Medical Devices
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Abbott Medical Devices
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kristin Ruffner, PhD Abbott
PRS Account Abbott Medical Devices
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP