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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06048731




Registration number
NCT06048731
Ethics application status
Date submitted
30/08/2023
Date registered
21/09/2023
Date last updated
4/11/2024

Titles & IDs
Public title
Enlighten Study: The EV-ICD Post Approval Registry
Scientific title
Enlighten Study: The EV-ICD Post Approval Registry
Secondary ID [1] 0 0
PSR: EV-ICD PAS/PMCF
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Defibrillation using EV-ICD

Treatment: Devices: Defibrillation using EV-ICD
Device: Defibrillation using the Extravascular ICD (EV-ICD)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complication-free survival rate
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
System and/or procedure related complication-free survival
Timepoint [1] 0 0
Procedure related complications assessed during and after the procedure/surgery; system related complications assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary outcome [2] 0 0
Abnormal battery depletion complications
Timepoint [2] 0 0
Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary outcome [3] 0 0
Summarize all device system revisions
Timepoint [3] 0 0
Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary outcome [4] 0 0
Patient deaths
Timepoint [4] 0 0
Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary outcome [5] 0 0
Patient demographics and baseline medical history
Timepoint [5] 0 0
Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary outcome [6] 0 0
Characterize extracardiac pacing sensation
Timepoint [6] 0 0
Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary outcome [7] 0 0
Summarize ATP with spontaneous arrhythmias
Timepoint [7] 0 0
Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary outcome [8] 0 0
Characterize asystole pacing
Timepoint [8] 0 0
Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary outcome [9] 0 0
Characterize sensing and detection
Timepoint [9] 0 0
Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary outcome [10] 0 0
To characterize defibrillation shock effectiveness for terminating spontaneous VT/VF arrhythmia
Timepoint [10] 0 0
Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Secondary outcome [11] 0 0
Characterize lead location and lead motion at implant.
Timepoint [11] 0 0
Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)

Eligibility
Key inclusion criteria
* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient is intended to receive or be treated with a EV-ICD device System and must be enrolled prior to the EV-ICD device implant procedure
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient who is, or is expected to be, inaccessible for follow-up
* Patient is excluded by local local law
* Patient is currently enrolled or plans to enroll in any concurrent drug and/or device study that may confound the PSR results

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2037
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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
Connecticut
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
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Austria
State/province [23] 0 0
Graz
Country [24] 0 0
Austria
State/province [24] 0 0
Innsbruck
Country [25] 0 0
Austria
State/province [25] 0 0
Linz
Country [26] 0 0
Austria
State/province [26] 0 0
Wien
Country [27] 0 0
Belgium
State/province [27] 0 0
Brugge
Country [28] 0 0
Belgium
State/province [28] 0 0
Brussels
Country [29] 0 0
Belgium
State/province [29] 0 0
Brussel
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
Quebec
Country [32] 0 0
Canada
State/province [32] 0 0
Montreal
Country [33] 0 0
Czechia
State/province [33] 0 0
Prague
Country [34] 0 0
Denmark
State/province [34] 0 0
Copenhagen
Country [35] 0 0
Denmark
State/province [35] 0 0
Odense
Country [36] 0 0
Finland
State/province [36] 0 0
Helsinki
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France
State/province [37] 0 0
Clermont Ferrand
Country [38] 0 0
France
State/province [38] 0 0
La Tronche
Country [39] 0 0
France
State/province [39] 0 0
Lille
Country [40] 0 0
France
State/province [40] 0 0
Montpellier
Country [41] 0 0
France
State/province [41] 0 0
Nantes Cedex 1
Country [42] 0 0
France
State/province [42] 0 0
Paris
Country [43] 0 0
France
State/province [43] 0 0
Pessac
Country [44] 0 0
France
State/province [44] 0 0
Rennes
Country [45] 0 0
France
State/province [45] 0 0
Saint-Avertin
Country [46] 0 0
Germany
State/province [46] 0 0
Bad Oeynhausen
Country [47] 0 0
Germany
State/province [47] 0 0
Bremen
Country [48] 0 0
Germany
State/province [48] 0 0
Hanover
Country [49] 0 0
Germany
State/province [49] 0 0
Stuttgart
Country [50] 0 0
Germany
State/province [50] 0 0
Tübingen
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Greece
State/province [51] 0 0
Thessaloníki
Country [52] 0 0
Hong Kong
State/province [52] 0 0
Hong Kong
Country [53] 0 0
Hungary
State/province [53] 0 0
Budapest
Country [54] 0 0
Israel
State/province [54] 0 0
Be'er Sheva
Country [55] 0 0
Israel
State/province [55] 0 0
Jerusalem
Country [56] 0 0
Israel
State/province [56] 0 0
Ramat Gan
Country [57] 0 0
Italy
State/province [57] 0 0
Ancona
Country [58] 0 0
Italy
State/province [58] 0 0
Bari
Country [59] 0 0
Italy
State/province [59] 0 0
Bologna
Country [60] 0 0
Italy
State/province [60] 0 0
Milano
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Italy
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Monza
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Kuwait
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Kuwait
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Netherlands
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Amsterdam
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Netherlands
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Den Haag
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Netherlands
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Enschede
Country [66] 0 0
Netherlands
State/province [66] 0 0
Groningen
Country [67] 0 0
Netherlands
State/province [67] 0 0
Leiden
Country [68] 0 0
Netherlands
State/province [68] 0 0
Nieuwegein
Country [69] 0 0
Netherlands
State/province [69] 0 0
Rotterdam
Country [70] 0 0
New Zealand
State/province [70] 0 0
Christchurch
Country [71] 0 0
Norway
State/province [71] 0 0
Oslo
Country [72] 0 0
Poland
State/province [72] 0 0
Poznan
Country [73] 0 0
Poland
State/province [73] 0 0
Warsaw
Country [74] 0 0
Poland
State/province [74] 0 0
Zabrze
Country [75] 0 0
Portugal
State/province [75] 0 0
Carnaxide
Country [76] 0 0
Portugal
State/province [76] 0 0
Lisboa
Country [77] 0 0
Saudi Arabia
State/province [77] 0 0
Jeddah
Country [78] 0 0
Saudi Arabia
State/province [78] 0 0
Riyadh
Country [79] 0 0
Spain
State/province [79] 0 0
Barcelona
Country [80] 0 0
Spain
State/province [80] 0 0
Coruña
Country [81] 0 0
Spain
State/province [81] 0 0
Córdoba
Country [82] 0 0
Spain
State/province [82] 0 0
Girona
Country [83] 0 0
Spain
State/province [83] 0 0
Granada
Country [84] 0 0
Spain
State/province [84] 0 0
Palma De Mallorca
Country [85] 0 0
Spain
State/province [85] 0 0
Valencia
Country [86] 0 0
Sweden
State/province [86] 0 0
Göteborg
Country [87] 0 0
Sweden
State/province [87] 0 0
Skåne
Country [88] 0 0
Switzerland
State/province [88] 0 0
Basel
Country [89] 0 0
Switzerland
State/province [89] 0 0
Bern
Country [90] 0 0
Switzerland
State/province [90] 0 0
Lausanne
Country [91] 0 0
Switzerland
State/province [91] 0 0
Lugano
Country [92] 0 0
Switzerland
State/province [92] 0 0
Zurich
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Leicester
Country [94] 0 0
United Kingdom
State/province [94] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm safety and effectiveness of EV-ICD in routine clinical practice, following commercial release of EV-ICD devices.
Trial website
https://clinicaltrials.gov/study/NCT06048731
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
EV-ICD PAS/PMCF Study manager
Address 0 0
Country 0 0
Phone 0 0
18006338766
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06048731