Ventricular ArrhythmiaNCT06048731
Enlighten Study: The EV-ICD Post Approval Registry
An observational study of Ventricular Arrhythmia and Tachycardia, run by Medtronic at 130 sites in 24 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventricular Arrhythmia, Tachycardia
- What is being tested?
- Defibrillation using EV-ICD
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 130 sitesin 24 countries
- Study dates
- 1 Sep 2023to 31 Oct 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients intended to be implanted with a EV-ICD system are eligible for enrollment and all patients must be consented prior to implant. Geographies with regulatory approval for the EV-ICD system are eligible to enroll patients (see locations section). All patients enrolled and successfully implanted with an EV-ICD system will be followed for lifetime of device, unless a patient is exited from the registry due to an unavoidable reason such as death, physician discretion, or patient withdrawal of consent. If EV-ICD system is not successfully implanted, patients will be exited from the registry unless a EV-ICD System and/or implant procedure related event is identified, for which the patient will be followed until the event is resolved or no further actions need to be taken.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
130 sites in 24 countries.
130 sites in 24 countries
United States57 sites
Presbyterian Heart Group
Albuquerque, New Mexico, 87106
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Northwell Health South Shore University Hospital
Bay Shore, New York, 11706
Saint Luke's University Health Network
Bethlehem, Pennsylvania, 18018
Massachusetts General Hospital
Boston, Massachusetts, 02114-2621
Brigham and Woman's Hospital
Boston, Massachusetts, 02115
University of Virginia Medical Center
Charlottesville, Virginia, 22908
The Christ Hospital Health Network CRD
Cincinnati, Ohio, 45219
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
OhioHealth Research Institute (OHRI)
Columbus, Ohio, 43214
Metropolitan Cardiology Consultants
Coon Rapids, Minnesota, 55433
Consultants in Cardiology (Fort Worth)
Dallas, Texas, 75226
Geisinger Medical Center
Danville, Pennsylvania, 17822
Duke University Medical Center (DUMC)
Durham, North Carolina, 27710
Heart Center of North Texas
Fort Worth, Texas, 76104
Hartford Hospital
Hartford, Connecticut, 06102
Northwell Health Huntington Hospital
Huntington, New York, 11743
Cardiology Associates Medical Group
Huntington Park, California, 93003
Baptist Health
Jacksonville, Florida, 32207
Saint Luke's Health System
Kansas City, Missouri, 64111
University of Kansas Medical Center Research Institute
Kansas City, Missouri, 66160
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Norton Heart and Vascular Institute
Louisville, Kentucky, 40205
Northwell Health North Shore University Hospital
Manhasset, New York, 11030
Wellstar Research Institute
Marietta, Georgia, 30060
Virtua Health
Marlton, New Jersey, 08053
The Stern Cardiovascular Foundation
Memphis, Tennessee, 38138
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
Atlantic Health System
Morristown, New Jersey, 07962
Vanderbilt University Medical Center
Nashville, Tennessee, 337232-8802
Saint Thomas Research Institute
Nashville, Tennessee, 37203
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
NYU Langone Medical Center
New York, New York, 10016-4972
New York-Presbyterian Hospital Columbia University
New York, New York, 10032
New York - Presbyterian Hospital / Weill Cornell Medical Center
New York, New York, 10065
Deaconess Specialty Physicians
Newburgh, Indiana, 47630
Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32405
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Medical Center UPMC Shadyside
Pittsburgh, Pennsylvania, 15232
University of Pittsburgh Medical Center UPMC Passavant
Pittsburgh, Pennsylvania, 15237
Baylor Research Institute
Plano, Texas, 75093
Hudson Valley Heart Center
Poughkeepsie, New York, 12601
Sequoia Hospital
Redwood City, California, 94062
Mayo Clinic
Rochester, Minnesota, 55905
TidalHealth Peninsula Regional
Salisbury, Maryland, 21801
University of California San Diego
San Diego, California, 92093
Intercoastal Medical Group
Sarasota, Florida, 34232
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford Hospital & Clinics
Stanford, California, 94305
Northwell Health Staten Island University Hospital
Staten Island, New York, 10305
Iowa Heart Center
West Des Moines, Iowa, 50266-8209
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
Michigan Heart
Ypsilanti, Michigan, 48197
France11 sites
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
Clermont-Ferrand, 63003
Centre Hospitalier Universitaire de Grenoble - Site Nord
La Tronche
Centre Hospitalier Régional Universitaire de Lille
Lille, 59037
OC Santé - Clinique du Millénaire
Montpellier
Hôpital Guillaume et René Laënnec - CHU de Nantes
Nantes, 44093
Hopital Pitie-Salpetriere AP-HP
Paris
Hôpital Européen Georges Pompidou
Paris
Institut Mutualiste Montsouris
Paris
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, 33604
CHU de Rennes - Hôpital Pontchaillou
Rennes
CHRU de Tours - Hôpital Trousseau
Saint-Avertin
Netherlands7 sites
Amsterdam UMC - Locatie AMC
Amsterdam
Medisch Spectrum Twente
Enschede
Universitair Medisch Centrum Groningen
Groningen
Leids Universitair Medisch Centrum (LUMC)
Leiden
St Antonius Ziekenhuis
Nieuwegein
Erasmus Medisch Centrum
Rotterdam
HagaZiekenhuis - Locatie Leyweg
The Hague
Spain6 sites
Hospital Universitario da Coruña
A Coruña
Hospital Universitari Bellvitge
Barcelona
Hospital Universitario Reina Sofía
Córdoba
Hospital Universitari de Girona Doctor Josep Trueta
Girona
Hospital Universitario Virgen de las Nieves
Granada
Hospital Universitario y Politécnico La Fe
Valencia
Germany5 sites
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
Bad Oeynhausen
Elektrophysiologie Bremen - Im Klinikum Links der Weser
Bremen, 28277
Medizinische Hochschule Hannover
Hanover
Robert-Bosch-Krankenhaus
Stuttgart
Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
Tübingen, 72076
Italy5 sites
Azienda Ospedaliera - Universitaria Consorziale Policlinico di Bari
Bari
Policlinico Di Sant Orsola Malpighi
Bologna
Azienda Ospedaliera Ospedale Niguarda Cà Granda
Milan, 20162
Centro Cardiologico Monzino
Milan
Azienda Ospedaliera San Gerardo
Monza
Switzerland5 sites
Universitätsspital Basel
Basel, 4031
Inselspital - Universitätsspital Bern
Bern
Centre Hospitalier Universitaire Vaudois
Lausanne
Istituto Cardiocentro Ticino
Lugano
UniversitätsSpital Zürich
Zurich
Austria4 sites
LKH - Universitätsklinikum Graz
Graz
Aö Landeskrankenhaus - Universitätskliniken Innsbruck
Innsbruck
Kepler Universitätsklinikum Med Campus III
Linz
Allgemeines Krankenhaus - Universitätskliniken Wien
Vienna
Canada4 sites
University Of Calgary
Calgary, Alberta, T2N2T9
Montreal Heart Institute
Montreal, Quebec, H1T1C8
McGill University Health Centre (MUHC)
Montreal
Institut Universitaire de Cardiologie et de Pneumo
Québec, Quebec, G1V4G5
Poland4 sites
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 61-848
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, 02-097
Narodowy Instytut Kardiologii - Stefana kardynała Wyszyńskiego
Warsaw, 04-628
Slaskie Centrum Chorob Serca
Zabrze
Belgium2 sites
AZ Sint Jan Brugge-Oostende av
Bruges
Cliniques Universitaires Saint-Luc
Brussels, 1200
Greece2 sites
Hippokration General Hospital of Athens
Athens
George Papanikolaou General Hospital
Thessaloniki
Israel2 sites
Shaare Zedek Medical Center
Jerusalem
Sheba Medical Center
Ramat Gan
Portugal2 sites
Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
Carnaxide
Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
Lisbon
Saudi Arabia2 sites
King Fahad Armed Forces Hospital
Jeddah, 21159
King Faisal Specialist Hospital & Research Centre
Riyadh
Sweden2 sites
Sahlgrenska Universitetssjukhuset
Gothenburg
Skånes Universitetssjukhus
Skåne
United Kingdom2 sites
Glenfield Hospital
Leicester
Kings College Hospital NHS Foundation Trust
London
About this study
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.
Read the detailed description
The Enlighten Study is a global, prospective, observational, multi-site registry study. This study is conducted within Medtronic's post-market surveillance platform.
Eligibility for enrollment is based on market release dates for EV-ICD System within the geography in which the subject is enrolled.
Patients enrolled in the Enlighten Study will be prospectively followed for the life time of device post-implant or until registry closure, patient death or patient exit from the registry (i.e., withdrawal of consent).
Successfully implanted patients are expected to have scheduled follow-up visits per routine clinical care, at least annually, or as prompted by reportable adverse events. The total estimated registry duration is through lifetime of device.
- Conditions
- Ventricular Arrhythmia, Tachycardia
- Being tested
- Defibrillation using EV-ICD
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defibrillation using EV-ICDDevice
Device: Defibrillation using the Extravascular ICD (EV-ICD)
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication-free survival rate
To demonstrate 5-year Aurora EV-ICD major system-related complication-free survival > 79%
Measured: 5 years
Secondary outcomes (11)
System and/or procedure related complication-free survival
To estimate the Aurora EV-ICD major system and/or procedure related complication-free survival probability as a function of time post-implant
Measured: 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)
Abnormal battery depletion complications
Characterize the rate of abnormal battery depletion complications as a function of time post-implant
Measured: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Summarize all device system revisions
Summarize all device system revisions (e.g., reposition, replacement, explant) including reasons for modification and action taken
Measured: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Patient deaths
Summarize patient deaths
Measured: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Patient demographics and baseline medical history
Summarize patient demographics and baseline medical history
Measured: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Characterize extracardiac pacing sensation
Characterize extracardiac pacing sensation
Measured: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Summarize ATP with spontaneous arrhythmias
Summarize ATP with spontaneous arrhythmias
Measured: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Characterize asystole pacing
Characterize asystole pacing
Measured: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Characterize sensing and detection
Characterize sensing and detection
Measured: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
To characterize defibrillation shock effectiveness for terminating spontaneous VT/VF arrhythmia
Characterize high voltage therapy effectiveness on device detected spontaneous ventricular episodes
Measured: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Characterize lead location and lead motion at implant.
Characterize lead location and lead motion at implant.
Measured: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Sep 2023
- Primary completion31 May 2030 (estimated)
- Study completion31 Oct 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventricular ArrhythmiaStudies of the same condition, open and under way.
- More trials run by MedtronicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048731
- Sponsor's protocol ID
- PSR: EV-ICD PAS/PMCF
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Boersma LVA, Amin A, Murgatroyd F, Sterlinski M, Johansen JB, Saleh K, Mason PK, Casares J, Engel G, Duncker D, Breitenstein A, Takata T, Epstein LM, van Opstal JM, Clementy N, Friedman P, Monfredi O, Gwechenberger M, Nishii N, Wiggenhorn C, Lande JD, Lee J, Thompson AE, Holmes TR, Crozier I; Enlighten Study Investigators. Real-World Experience With the Extravascular Implantable Cardioverter Defibrillator Through 1 Year: The Enlighten Post Approval Registry Study. Circulation. 2026 Sep 22. doi: 10.1161/CIRCULATIONAHA.126.080942. Online ahead of print.
PubMed 42770223Boersma LVA, Amin A, Clementy N, Duncker D, Engel G, Epstein L, Kuriachan V, Frazier-Mills C, Gwechenberger M, Nishii N, Lande J, Wiggenhorn C, Crozier I. Design of a post-market registry for the extravascular implantable cardioverter-defibrillator: The Enlighten Study. Heart Rhythm O2. 2024 Oct 16;6(1):64-69. doi: 10.1016/j.hroo.2024.09.022. eCollection 2025 Jan.
PubMed 40224263Crozier I, Murgatroyd F, Amin A, Clementy N, Duncker D, Kotschet E, Wiggenhorn C, Boersma LVA. Periprocedural outcomes from the postmarket study of the extravascular implantable cardioverter-defibrillator: Preliminary Enlighten study results and meta-analysis. Heart Rhythm. 2026 Jan;23(1):180-185. doi: 10.1016/j.hrthm.2025.02.012. Epub 2025 Apr 2.
PubMed 40172499
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enlighten Study: The EV-ICD Post Approval Registry
- ClinicalTrials.gov ID
- NCT06048731
- Acronym / sponsor ID
- PSR: EV-ICD PAS/PMCF
- Conditions
- Ventricular Arrhythmia, Tachycardia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 Oct 2037 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Enlighten Study is a global, prospective, observational, multi-site registry study. This study is conducted within Medtronic's post-market surveillance platform.
Eligibility for enrollment is based on market release dates for EV-ICD System within the geography in which the subject is enrolled.
Patients enrolled in the Enlighten Study will be prospectively followed for the life time of device post-implant or until registry closure, patient death or patient exit from the registry (i.e., withdrawal of consent).
Successfully implanted patients are expected to have scheduled follow-up visits per routine clinical care, at least annually, or as prompted by reportable adverse events. The total estimated registry duration is through lifetime of device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients intended to be implanted with a EV-ICD system are eligible for enrollment and all patients must be consented prior to implant. Geographies with regulatory approval for the EV-ICD system are eligible to enroll patients (see locations section). All patients enrolled and successfully implanted with an EV-ICD system will be followed for lifetime of device, unless a patient is exited from the registry due to an unavoidable reason such as death, physician discretion, or patient withdrawal of consent. If EV-ICD system is not successfully implanted, patients will be exited from the registry unless a EV-ICD System and/or implant procedure related event is identified, for which the patient will be followed until the event is resolved or no further actions need to be taken.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Defibrillation using EV-ICDDevice: Defibrillation using the Extravascular ICD (EV-ICD) | Device | – |
Primary outcome
Complication-free survival rate
Time frame: 5 years
To demonstrate 5-year Aurora EV-ICD major system-related complication-free survival > 79%
11 secondary outcomes
System and/or procedure related complication-free survival
Time frame: 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)
Abnormal battery depletion complications
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Summarize all device system revisions
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Patient deaths
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Patient demographics and baseline medical history
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Characterize extracardiac pacing sensation
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Summarize ATP with spontaneous arrhythmias
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Characterize asystole pacing
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Characterize sensing and detection
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
To characterize defibrillation shock effectiveness for terminating spontaneous VT/VF arrhythmia
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Characterize lead location and lead motion at implant.
Time frame: Assessed through the study completion (12 years average), and assessed every year (1 year, 2 years, 3 years, … 12 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 42770223Boersma LVA, Amin A, Murgatroyd F, Sterlinski M, Johansen JB, Saleh K, Mason PK, Casares J, Engel G, Duncker D, Breitenstein A, Takata T, Epstein LM, van Opstal JM, Clementy N, Friedman P, Monfredi O, Gwechenberger M, Nishii N, Wiggenhorn C, Lande JD, Lee J, Thompson AE, Holmes TR, Crozier I; Enlighten Study Investigators. Real-World Experience With the Extravascular Implantable Cardioverter Defibrillator Through 1 Year: The Enlighten Post Approval Registry Study. Circulation. 2026 Sep 22. doi: 10.1161/CIRCULATIONAHA.126.080942. Online ahead of print.
- Derived from this study: PubMed 40224263Boersma LVA, Amin A, Clementy N, Duncker D, Engel G, Epstein L, Kuriachan V, Frazier-Mills C, Gwechenberger M, Nishii N, Lande J, Wiggenhorn C, Crozier I. Design of a post-market registry for the extravascular implantable cardioverter-defibrillator: The Enlighten Study. Heart Rhythm O2. 2024 Oct 16;6(1):64-69. doi: 10.1016/j.hroo.2024.09.022. eCollection 2025 Jan.
- Derived from this study: PubMed 40172499Crozier I, Murgatroyd F, Amin A, Clementy N, Duncker D, Kotschet E, Wiggenhorn C, Boersma LVA. Periprocedural outcomes from the postmarket study of the extravascular implantable cardioverter-defibrillator: Preliminary Enlighten study results and meta-analysis. Heart Rhythm. 2026 Jan;23(1):180-185. doi: 10.1016/j.hrthm.2025.02.012. Epub 2025 Apr 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
130 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Arrhythmia and Tachycardia, run by Medtronic at 130 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 130 sites in United States, France, Netherlands, Spain, Germany and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication-free survival rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06048731, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.