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

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ClinicalTrials.gov Identifier: NCT03490201
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

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.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Device: Market Approved RF Ablation System Device: FlexAbility SE Ablation Catheter Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 592 participants
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
Official Title: FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Randomized - Control Device: Market Approved RF Ablation System
Subjects receive ablation using an FDA approved ablation system.

Active Comparator: Randomized - Treatment Device: FlexAbility SE Ablation Catheter
Subjects receive ablation treatment using an ablation system that is not FDA approved.

Experimental: Non-randomized - Treatment Device: FlexAbility SE Ablation Catheter
Subjects receive ablation treatment using an ablation system that is not FDA approved.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

    • Confirmed diagnosis via echocardiography and/or cardiac MRI, or
    • Left ventricular ejection fraction (EF) <40% (documented within the last 6 months via TTE, 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

  • 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490201


Contacts
Contact: Nicole Glowacki, MS 651-756-3432 nicole.glowacki@abbott.com
Contact: Amber Miller, PhD 651-756-2885 amber.miller@abbott.com

Locations
United States, Alabama
University Hospital - Univ. of Alabama at Birmingham (UAB) Recruiting
Birmingham, Alabama, United States, 35249
Contact: Hugh Thomas McElderry, MD    205-934-2525    tommcelderry@uab.edu   
United States, California
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Jason Bradfield, MD    310-206-2235    JBradfield@mednet.ucla.edu   
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Wendy Tzou, MD    720-848-6510    wendy.tzou@ucdenver.edu   
United States, Florida
Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33020
Contact: Daniel Benhayon, MD    954-981-3331    danbenhayon@yahoo.com   
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Anshul Patel, MD    770-757-6455    anshul.patel@emoryhealthcare.org   
United States, Maryland
Johns Hopkins University Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Harikrishna Tandri, MD    410-903-1182    htandri1@jhmi.edu   
United States, Minnesota
VA Medical Center Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Venkatakrishna Tholakanahalli, MD    612-467-3662    thola001@umn.edu   
United States, North Carolina
WakeMed Hospital Recruiting
Raleigh, North Carolina, United States, 27610
Contact: Patrick Hranitzky, MD    919-724-2281    phranitzky@tcaheart.com   
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: David Frankel, MD    215-662-6801    David.frankel@uphs.upenn.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jeffrey Winterfield, MD    843-876-4760    winterfj@musc.edu   
United States, Texas
Texas Cardiac Arrhythmia Recruiting
Austin, Texas, United States, 78705
Contact: David Burkhardt    512-807-3150    tcarfjdb@gmail.com   
Czechia
IKEM Recruiting
Prague, Central Bohemia, Czechia, 14021
Contact: Josef Kautzner, MD         
Nemocnice Na Homolce Recruiting
Prague, Czechia, 15030
Contact: Petr Neuzil, MD    420257272211    petr.neuzil@homolka.cz   
France
Hopital Haut Leveque Recruiting
Pessac, France, 33604
Contact: Frédéric Sacher, MD    +33 557623172    frederic.sacher@chu-bordeaux.fr   
Germany
Herzzentrum Leipzig GmbH Recruiting
Leipzig, Germany, 04289
Contact: Gerhard Hindricks, Prof. Dr.    00493418651413    Gerhard.Hindricks@helios-kliniken.de   
Italy
Ospedale San Raffaele Recruiting
Milan, Italy, 20132
Contact: Paolo Della Bella, Prof    390226436247    dellabella.paolo@hsr.it   
Centro Cardiologico Monzino Recruiting
Milan, Italy, 20138
Contact: Claudio Tondo, Prof.    390658701    claudio.tondo@ccfm.it   
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Kristin Ruffner, PhD Abbott

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT03490201     History of Changes
Other Study ID Numbers: SJM-CIP-10138
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes