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Extravascular ICD Pivotal Study (EV ICD)

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ClinicalTrials.gov Identifier: NCT04060680
Recruitment Status : Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
The study is designed to demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.

Condition or disease Intervention/treatment Phase
Tachycardia Ventricular Arrythmia Device: Defibrillation Not Applicable

Detailed Description:
The study will enroll subjects who are indicated to receive an implantable defibrillator and 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 for at least 6 months following system implantation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Extravascular ICD Pivotal Study (EV ICD)
Estimated Study Start Date : October 31, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Experimental
Patients will be implanted with an extravascular ICD and undergo requisite electrical testing.
Device: Defibrillation
VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.




Primary Outcome Measures :
  1. Safety Outcome - Freedom from major complications related to the EV ICD System and/or procedure at 6 months post-implant [ Time Frame: 6 Months ]
    Subjects will be monitored to determine whether they experience a major procedure- or system-related complication within 6 months post-implant.

  2. Efficacy Outcome - Defibrillation efficacy at implant of the EV ICD System [ Time Frame: At Implant, up to 2 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
    • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060680


Contacts
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Contact: Jo Krueger 6122712848 jo.krueger@medtronic.com

Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Principal Investigator: Paul Friedman, MD Mayo Clinic

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT04060680     History of Changes
Other Study ID Numbers: U1111-1236-4810
MDT16028 ( Other Identifier: Medtronic )
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes