Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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

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
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Austria
State/province [22] 0 0
Graz
Country [23] 0 0
Austria
State/province [23] 0 0
Innsbruck
Country [24] 0 0
Austria
State/province [24] 0 0
Linz
Country [25] 0 0
Austria
State/province [25] 0 0
Wien
Country [26] 0 0
Belgium
State/province [26] 0 0
Brugge
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussel
Country [28] 0 0
Canada
State/province [28] 0 0
Alberta
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Canada
State/province [30] 0 0
Montreal
Country [31] 0 0
Czechia
State/province [31] 0 0
Prague
Country [32] 0 0
Denmark
State/province [32] 0 0
Odense
Country [33] 0 0
Finland
State/province [33] 0 0
Helsinki
Country [34] 0 0
France
State/province [34] 0 0
Clermont Ferrand
Country [35] 0 0
France
State/province [35] 0 0
La Tronche
Country [36] 0 0
France
State/province [36] 0 0
Lille
Country [37] 0 0
France
State/province [37] 0 0
Montpellier
Country [38] 0 0
France
State/province [38] 0 0
Nantes Cedex 1
Country [39] 0 0
France
State/province [39] 0 0
Paris
Country [40] 0 0
France
State/province [40] 0 0
Pessac
Country [41] 0 0
France
State/province [41] 0 0
Rennes
Country [42] 0 0
France
State/province [42] 0 0
Saint-Avertin
Country [43] 0 0
Germany
State/province [43] 0 0
Bad Oeynhausen
Country [44] 0 0
Germany
State/province [44] 0 0
Bremen
Country [45] 0 0
Germany
State/province [45] 0 0
Hanover
Country [46] 0 0
Germany
State/province [46] 0 0
Stuttgart
Country [47] 0 0
Germany
State/province [47] 0 0
Tübingen
Country [48] 0 0
Greece
State/province [48] 0 0
Thessaloníki
Country [49] 0 0
Hong Kong
State/province [49] 0 0
Hong Kong
Country [50] 0 0
Hungary
State/province [50] 0 0
Budapest
Country [51] 0 0
Israel
State/province [51] 0 0
Ramat Gan
Country [52] 0 0
Italy
State/province [52] 0 0
Bari
Country [53] 0 0
Italy
State/province [53] 0 0
Milano
Country [54] 0 0
Kuwait
State/province [54] 0 0
Kuwait
Country [55] 0 0
Netherlands
State/province [55] 0 0
Amsterdam
Country [56] 0 0
Netherlands
State/province [56] 0 0
Den Haag
Country [57] 0 0
Netherlands
State/province [57] 0 0
Enschede
Country [58] 0 0
Netherlands
State/province [58] 0 0
Groningen
Country [59] 0 0
Netherlands
State/province [59] 0 0
Leiden
Country [60] 0 0
Netherlands
State/province [60] 0 0
Nieuwegein
Country [61] 0 0
Netherlands
State/province [61] 0 0
Rotterdam
Country [62] 0 0
New Zealand
State/province [62] 0 0
Christchurch
Country [63] 0 0
Norway
State/province [63] 0 0
Oslo
Country [64] 0 0
Poland
State/province [64] 0 0
Poznan
Country [65] 0 0
Poland
State/province [65] 0 0
Warsaw
Country [66] 0 0
Poland
State/province [66] 0 0
Zabrze
Country [67] 0 0
Portugal
State/province [67] 0 0
Carnaxide
Country [68] 0 0
Portugal
State/province [68] 0 0
Lisboa
Country [69] 0 0
Saudi Arabia
State/province [69] 0 0
Riyadh
Country [70] 0 0
Spain
State/province [70] 0 0
Barcelona
Country [71] 0 0
Spain
State/province [71] 0 0
Coruña
Country [72] 0 0
Spain
State/province [72] 0 0
Córdoba
Country [73] 0 0
Spain
State/province [73] 0 0
Girona
Country [74] 0 0
Spain
State/province [74] 0 0
Granada
Country [75] 0 0
Spain
State/province [75] 0 0
Palma De Mallorca
Country [76] 0 0
Spain
State/province [76] 0 0
Valencia
Country [77] 0 0
Sweden
State/province [77] 0 0
Göteborg
Country [78] 0 0
Sweden
State/province [78] 0 0
Skåne
Country [79] 0 0
Switzerland
State/province [79] 0 0
Bern
Country [80] 0 0
Switzerland
State/province [80] 0 0
Lausanne
Country [81] 0 0
Switzerland
State/province [81] 0 0
Lugano
Country [82] 0 0
Switzerland
State/province [82] 0 0
Zurich
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Leicester
Country [84] 0 0
United Kingdom
State/province [84] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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/NCT06048731