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TachycardiaEV ICD CANCT05049720

ExtraVascular Implantable Cardiac Defibrillator Continued Access Study

A study testing Defibrillation using the Extravascular ICD in people with Tachycardia and Ventricular Arrythmia, run by Medtronic.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System. 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
0 participants
Where
No sites listed yet
Study dates
Sep 2022to 28 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

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 for their participation in the study.
  • 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.

Who cannot join

  • Patient has indications for bradycardia pacing[2] or Cardiac Resynchronization Therapy (CRT)[3] (Class I, IIa, or IIb indication).
  • Patients with an existing pacemaker, ICD, or CRT device 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)
  • Prior abdominal surgery in the epigastric region
Show all 35Show fewer
  • Planned sternotomy
  • Prior chest radiotherapy
  • Or any other prior/planned medical intervention not listed that precludes their participation in the opinion of the Investigator.
  • 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 that impedes the substernal tunneling path or procedure)
  • 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
  • Current 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 childbearing potential and who are not on a reliable form of birth regulation method or abstinence*
  • (If required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to EV ICD Continued Access Study procedures)

About this study

This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.

Read the detailed description

The study will enroll subjects who are indicated to receive an implantable defibrillator who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will receive an investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver defibrillation therapy. Subjects will be followed every 6 months following system implantation.

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 groups in NCT05049720
Study groupRoleWhat they receive
ExperimentalExperimentalPatients 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.

  1. Complications

    EV ICD system and/or procedure related adverse events

    Measured: Through study completion, an average of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2021
  2. Study startSep 2022 (estimated)
  3. Primary completion28 Jul 2023 (estimated)
  4. Study completion28 Jul 2023 (estimated)

Why it stopped: The NCT posting for the study has been transferred to NCT04060680

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05049720
Sponsor's protocol ID
MDT20054
Acronym
EV ICD CA
Status last verified
Sep 2022
First submitted
26 Aug 2021
Last updated
10 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Granger CB, Hammill SC, Hlatky MA, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2018 Oct 2;72(14):e91-e220. doi: 10.1016/j.jacc.2017.10.054. Epub 2018 Aug 16. No abstract available.

    PubMed 29097296

  • Wilkoff BL, Fauchier L, Stiles MK, Morillo CA, Al-Khatib SM, Almendral J, Aguinaga L, Berger RD, Cuesta A, Daubert JP, Dubner S, Ellenbogen KA, Mark Estes NA 3rd, Fenelon G, Garcia FC, Gasparini M, Haines DE, Healey JS, Hurtwitz JL, Keegan R, Kolb C, Kuck KH, Marinskis G, Martinelli M, McGuire M, Molina LG, Okumura K, Proclemer A, Russo AM, Singh JP, Swerdlow CD, Teo WS, Uribe W, Viskin S, Wang CC, Zhang S. 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing. Heart Rhythm. 2016 Feb;13(2):e50-86. doi: 10.1016/j.hrthm.2015.11.018. Epub 2015 Dec 1. No abstract available.

    PubMed 26607062

  • Kusumoto FM, Schoenfeld MH, Barrett C, Edgerton JR, Ellenbogen KA, Gold MR, Goldschlager NF, Hamilton RM, Joglar JA, Kim RJ, Lee R, Marine JE, McLeod CJ, Oken KR, Patton KK, Pellegrini CN, Selzman KA, Thompson A, Varosy PD. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019 Aug 20;74(7):e51-e156. doi: 10.1016/j.jacc.2018.10.044. Epub 2018 Nov 6. No abstract available.

    PubMed 30412709

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.

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 35 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: withdrawn, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Complications (time frame: Through study completion, an average of 18 months). 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 NCT05049720, 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 10 Sep 2022.

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