TachycardiaNCT07091916
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
A study testing Defibrillation using the Extravascular ICD in people with Tachycardia and Ventricular Arrythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Japan.
Trial summary
The study is designed to characterize the acute safety and performance of the EV ICD System for Japanese patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Ventricular Arrythmia
- What is being tested?
- Defibrillation using the Extravascular ICD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteJapan
- Study dates
- 22 Feb 2023to 23 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines [i], or ESC guidelines [ii].
- Patient is at least 18 years of age and meets age requirements per local law.
- Patient is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up.
- [i] Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Hlatky MA, Granger CB, Hammill SC, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias. [ii] Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliot PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ. 2015 ESC guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. European Heart Journal 2015 36:41 (2793-2867). https://doi.org/10.1093/eurheartj/ehv316
Who cannot join
- Patient is unwilling or unable to personally provide Informed Consent.
- Patient has indications for bradycardia pacing [iii] or Cardiac Resynchronization Therapy (CRT) [iv] (Class I, IIa, or IIb indication).
- Patient with an existing pacemaker, ICD, or CRT device implant or leads.
- Patients with these medical interventions are excluded from participation in the study:
- Prior sternotomy
- Any prior medical condition or procedure that leads to adhesions in the anterior mediastinal space (i.e., prior mediastinal instrumentation, mediastinitis)
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- Prior abdominal surgery in the epigastric region
- Planned sternotomy
- Prior chest radiotherapy
- Or any other prior/planned medical intervention not listed that precludes their participation in the opinion of the Investigator.
- Patient has previous pericarditis that:
- Was chronic and recurrent, or
- Resulted in pericardial effusion [v], or
- Resulted in pericardial thickening or calcification [vi].
- Patients with these medical conditions or anatomies are excluded from participation in the study:
- Hiatal hernia that distorts mediastinal anatomy
- Marked sternal abnormality (e.g., pectus excavatum)
- Decompensated heart failure
- COPD with oxygen dependence
- Gross hepatosplenomegaly Or any other known medical condition or anatomy type not listed that precludes their participation in the opinion of the Investigator.
- Patients with a medical condition that precludes them from undergoing defibrillation testing:
- Severe aortic stenosis
- Intracardiac LA or LV thrombus
- Severe proximal three-vessel or left main coronary artery disease without revascularization
- Hemodynamic instability
- Unstable angina
- Recent stroke or transient ischemic attack (within the last 6 months)
- Known inadequate external defibrillation
- LVEF <20%
- LVEDD >70 mm Or any other known medical condition not listed that precludes their participation in the opinion of the Investigator.
- Patient with any evidence of active infection or undergoing treatment for an infection.
- Patient is contraindicated from temporary suspension of oral/systemic anticoagulation
- Patient with current implantation of neurostimulator or any other chronically implanted device that delivers current in the body.
- Patient meets ACC/AHA/HRS or ESC clinical guideline Class III criteria for an ICD (e.g., life expectancy of less than 12 months).
- Patient is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.
- Patient with any exclusion criteria as required by local law (e.g., age or other).
- Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence.
- [iii] 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing). [iv] ACC/AHA/HRS guidelines for Cardiac Resynchronization Therapy. [v] As documented on echo or MRI. [vi] As documented on CT scan or MRI.
Trial locations and contacts
1 site in 1 country.
About this study
The study is designed to characterize the acute safety and performance of the EV ICD System for Japanese patients.
- Conditions
- Tachycardia, Ventricular Arrythmia
- Being tested
- Defibrillation using the Extravascular 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 the Extravascular ICDDevice
VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.
| Study group | Role | What they receive |
|---|---|---|
| Implant Attempt | Experimental | Patients will be implanted with an extravascular ICD and undergo requisite electrical testing. Receives: Device: Defibrillation using the Extravascular ICD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 2 Weeks Post-implant
The endpoint is defined as a subject's first occurrence of a major complication related to the EV ICD System and/or procedure, as determined by an independent Clinical Events Committee (CEC), that occurs on or prior to 2 weeks (14 days) post-implant.
Measured: 2 weeks (14 days) post-implant
Efficacy Outcome - Defibrillation Efficacy at Implant of the EV ICD System
Each subject will demonstrate a successful defibrillation outcome if either 2 successive induced ventricular fibrillation episodes are terminated by the subject's device delivering a shock at the required energy level, or if one such episode is successfully terminated by the subject's device delivering a shock at a lower energy level. Up to 6 such episodes may be induced to test device efficacy.
Measured: At Implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start22 Feb 2023
- Primary completion16 Nov 2023
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TachycardiaStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091916
- Sponsor's protocol ID
- MDT22010
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 3 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
- ClinicalTrials.gov ID
- NCT07091916
- Acronym / sponsor ID
- MDT22010
- Conditions
- Tachycardia, Ventricular Arrythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 29 Jul 2025 (actual)
- Results
- Posted 3 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to characterize the acute safety and performance of the EV ICD System for Japanese patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant Attempt | Experimental | Device: Defibrillation using the Extravascular ICDPatients will be implanted with an extravascular ICD and undergo requisite electrical testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines [i], or ESC guidelines [ii].
- Patient is at least 18 years of age and meets age requirements per local law.
- Patient is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up.
- [i] Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Hlatky MA, Granger CB, Hammill SC, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias. [ii] Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliot PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ. 2015 ESC guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. European Heart Journal 2015 36:41 (2793-2867). https://doi.org/10.1093/eurheartj/ehv316
Key exclusion criteria (38 listed)
- Patient is unwilling or unable to personally provide Informed Consent.
- Patient has indications for bradycardia pacing [iii] or Cardiac Resynchronization Therapy (CRT) [iv] (Class I, IIa, or IIb indication).
- Patient with an existing pacemaker, ICD, or CRT device implant or leads.
- Patients with these medical interventions are excluded from participation in the study:
- Or any other prior/planned medical intervention not listed that precludes their participation in the opinion of the Investigator.
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 the Extravascular ICDVT/VF induction attempted for defibrillation testing, as well as requisite electrical testing. | Device | Implant Attempt |
Primary outcome
Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 2 Weeks Post-implant
Time frame: 2 weeks (14 days) post-implant
The endpoint is defined as a subject's first occurrence of a major complication related to the EV ICD System and/or procedure, as determined by an independent Clinical Events Committee (CEC), that occurs on or prior to 2 weeks (14 days) post-implant.
Efficacy Outcome - Defibrillation Efficacy at Implant of the EV ICD System
Time frame: At Implant
Each subject will demonstrate a successful defibrillation outcome if either 2 successive induced ventricular fibrillation episodes are terminated by the subject's device delivering a shock at the required energy level, or if one such episode is successfully terminated by the subject's device delivering a shock at a lower energy level. Up to 6 such episodes may be induced to test device efficacy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defibrillation using the Extravascular ICD in people with Tachycardia and Ventricular Arrythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Japan.
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 4 inclusion and 38 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: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Yes. Results are posted in the registry (first posted 3 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 2 Weeks Post-implant (time frame: 2 weeks (14 days) post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2025.