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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03490201




Registration number
NCT03490201
Ethics application status
Date submitted
28/08/2017
Date registered
6/04/2018

Titles & IDs
Public title
FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study
Scientific title
FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study
Secondary ID [1] 0 0
SJM-CIP-10138
Universal Trial Number (UTN)
Trial acronym
LESS-VT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventricular Tachycardia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Market Approved RF Ablation System
Treatment: Devices - FlexAbility SE Ablation Catheter

Active comparator: Randomized - Control - 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.

Active comparator: Randomized - Treatment - 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.

Experimental: Non-randomized - Treatment - 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.


Treatment: Devices: Market Approved RF Ablation System
Subjects receive ablation using an FDA approved radiofrequency (RF) ablation system.

Treatment: Devices: FlexAbility SE Ablation Catheter
Subjects receive ablation treatment using an ablation system that is not FDA approved.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of complications
Timepoint [1] 0 0
7 days
Primary outcome [2] 0 0
Freedom from recurrence of VT
Timepoint [2] 0 0
6 months

Eligibility
Key inclusion criteria
* 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
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 [atrial fibrillation], 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 [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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/04/2024
Sample size
Target
Accrual to date
Final
592
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Czechia
State/province [16] 0 0
Central Bohemia
Country [17] 0 0
Czechia
State/province [17] 0 0
Prague
Country [18] 0 0
France
State/province [18] 0 0
Pessac
Country [19] 0 0
Germany
State/province [19] 0 0
Leipzig
Country [20] 0 0
Italy
State/province [20] 0 0
Milan
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
United Kingdom
State/province [22] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kristin Ruffner, PhD
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03490201