TachycardiaEV ICDNCT03608670
Extravascular ICD Pilot 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 4 sites in 2 countries.
Trial summary
The proposed study is designed to characterize the safety and efficacy of a new extravascular implantable cardioverter defibrillator (ICD) system in humans. 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
- 26 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 17 Jul 2018to 15 Nov 2023
- 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[1]
- Patient is willing and able to sign and date the Informed Consent Form.
- Patient is at least 18 years of age and meets age requirements per local law
- Patient is geographically stable and willing and able to comply with the study procedures and visits for the duration of the follow-up
- [1] 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
- -
Who cannot join
- Patient has indications for bradycardia pacing [1] or Cardiac Resynchronization Therapy (CRT) [2] (Class I, IIa, or IIb indication)
- Patient has an existing or had a prior pacemaker, ICD, or CRT device implant or leads
- Patient has anatomical abnormality that significantly increases implant risk[3] including:
- Severe obesity [4]
- Marked RV dilation
- Marked sternal abnormality
Show all 38Show fewer
- Hiatus hernia that distorts mediastinal anatomy
- Patient has prior chest radiotherapy
- Patient had previous mediastinitis
- Patient had previous coronary artery bypass grafting procedure
- Patient has existing transcatheter aortic valve replacement
- Patient has gastrostomy tube
- Patient has had a prior sternotomy, prior mediastinal instrumentation, prior abdominal surgery in the epigastric region, or planned sternotomy
- Patient has previous pericarditis that:
- Was chronic and recurrent, or
- Resulted in pericardial effusion [5], or
- Resulted in pericardial thickening or calcification [6]
- Patients with a medical condition that precludes them from undergoing defibrillation testing, such as:
- known LV thrombus
- decompensated heart failure
- LVEF <20% [7]
- other physician discretion
- Patient has persistent Atrial Fibrillation who is at high risk of a thromboembolic event with a CHA₂DS₂-VASc score ≥3, or is contraindicated for having anticoagulation interrupted for ≥72 hours
- Patients with comorbidities which may increase surgical risk of complications[8] including:
- severe aortic stenosis
- COPD and is oxygen dependent
- Hepatosplenomegaly
- Marked hepatomegaly
- Patient is on renal dialysis
- Patient with any evidence of active infection or undergoing treatment for an infection
- Patient with current implantation of neurostimulator or any other chronically implanted device which uses current in the body.
- Patients with a limited life expectancy of less than 12 months
- Patient is enrolled or planning to enroll in a concurrent drug or device 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, pregnancy, breast feeding)
- 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 [9]
- [1] 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing).
- [2] ACC/AHA/HRS guidelines for Cardiac Resynchronization Therapy [3] Per physician discretion [4] BMI > 40 [5] As documented on echo or MRI [6] As documented on CT scan or MRI [7] Most recent LVEF in the last 180 days (inclusive) [8] Per physician discretion [9] if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to EV ICD Pilot Study procedures
- -
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia3 sites
The Prince Charles Hospital
Brisbane
MonashHeart
Clayton
Austin Health
Heidelberg
About this study
The proposed study is designed to characterize the safety and efficacy of a new extravascular implantable cardioverter defibrillator (ICD) system in humans.
Read the detailed description
The study will recruit male and female adult subjects that meet all of the inclusion criteria and none of the exclusion criteria. All subjects will be indicated to receive an ICD.
The EV ICD system will be implanted and the subjects will be followed for at least 3 months following implantation of the system.
Subjects will be exited after follow-up is completed.
- 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 |
|---|---|---|
| Experimental | 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.
Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation
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 5 such episodes may be induced to test device efficacy.
Measured: At Implantation
Safety Outcome - Percentage of Participants With Freedom From Major System and Procedure Related Complications at 3 Months (90 Days)
Subjects will be monitored to determine whether they experience a major procedure- or system-related complication within 3 months (90 days) post-implant.
Measured: 3 months (90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start17 Jul 2018
- Primary completion11 Mar 2019
- Study completion15 Nov 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TachycardiaStudies of the same condition, open and under way.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ian G Crozier, MB ChB, Principal investigator, Christchurch Hospital, Christchurch, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608670
- Sponsor's protocol ID
- MDT17034
- Acronym
- EV ICD
- Status last verified
- Jan 2024
- First submitted
- 12 Jun 2018
- Last updated
- 8 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Crozier I, Haqqani H, Kotschet E, Shaw D, Prabhu A, Roubos N, Alison J, Melton I, Denman R, Lin T, Almeida A, Portway B, Sawchuk R, Thompson A, Sherfesee L, Liang S, Lentz L, DeGroot P, Cheng A, O'Donnell D. First-in-Human Chronic Implant Experience of the Substernal Extravascular Implantable Cardioverter-Defibrillator. JACC Clin Electrophysiol. 2020 Nov;6(12):1525-1536. doi: 10.1016/j.jacep.2020.05.029. Epub 2020 Aug 26.
PubMed 33213813
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extravascular ICD Pilot Study
- ClinicalTrials.gov ID
- NCT03608670
- Acronym / sponsor ID
- EV ICD / MDT17034
- Conditions
- Tachycardia, Ventricular Arrythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 11 Mar 2019 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 22 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is designed to characterize the safety and efficacy of a new extravascular implantable cardioverter defibrillator (ICD) system in humans.
Detailed description
The study will recruit male and female adult subjects that meet all of the inclusion criteria and none of the exclusion criteria. All subjects will be indicated to receive an ICD.
The EV ICD system will be implanted and the subjects will be followed for at least 3 months following implantation of the system.
Subjects will be exited after follow-up is completed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | 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 (6 listed)
- Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines[1]
- Patient is willing and able to sign and date the Informed Consent Form.
- Patient is at least 18 years of age and meets age requirements per local law
- Patient is geographically stable and willing and able to comply with the study procedures and visits for the duration of the follow-up
- [1] 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
Key exclusion criteria (38 listed)
- Patient has indications for bradycardia pacing [1] or Cardiac Resynchronization Therapy (CRT) [2] (Class I, IIa, or IIb indication)
- Patient has an existing or had a prior pacemaker, ICD, or CRT device implant or leads
- Patient has anatomical abnormality that significantly increases implant risk[3] including:
- Patient has prior chest radiotherapy
- Patient had previous mediastinitis
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 | Experimental |
Primary outcome
Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation
Time frame: At Implantation
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 5 such episodes may be induced to test device efficacy.
Safety Outcome - Percentage of Participants With Freedom From Major System and Procedure Related Complications at 3 Months (90 Days)
Time frame: 3 months (90 days)
Subjects will be monitored to determine whether they experience a major procedure- or system-related complication within 3 months (90 days) post-implant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33213813Crozier I, Haqqani H, Kotschet E, Shaw D, Prabhu A, Roubos N, Alison J, Melton I, Denman R, Lin T, Almeida A, Portway B, Sawchuk R, Thompson A, Sherfesee L, Liang S, Lentz L, DeGroot P, Cheng A, O'Donnell D. First-in-Human Chronic Implant Experience of the Substernal Extravascular Implantable Cardioverter-Defibrillator. JACC Clin Electrophysiol. 2020 Nov;6(12):1525-1536. doi: 10.1016/j.jacep.2020.05.029. Epub 2020 Aug 26.
- 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.
Ian G Crozier, MB ChB principal investigator
Christchurch Hospital, Christchurch, New Zealand
4 sites in 2 countries: 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 4 sites in 2 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 6 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 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, New Zealand. 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 22 Apr 2022). 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?
Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation (time frame: At Implantation). 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?
On the ClinicalTrials.gov record for NCT03608670, which also lists 1 linked publication.
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 Jan 2024.