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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 : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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

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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: 7 days ]
    The primary safety endpoint is a composite of cardiovascular-related and procedure-related major complications through 7 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 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.

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

  Show 27 Study Locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Kristin Ruffner, PhD Abbott

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Responsible Party: Abbott Medical Devices
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: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes