ExtraVascular Implantable Cardiac Defibrillator Continued Access Study (EV ICD CA)

September 6, 2022 updated by: Medtronic
This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines.[1]
  2. Patient is willing and able to sign and date the Informed Consent Form for their participation in the study.
  3. Patient is at least 18 years of age and meets age requirements per local law.
  4. Patient is geographically stable and willing and able to comply with the study procedures and visits for the duration of the follow-up.

Exclusion Criteria:

  1. Patient has indications for bradycardia pacing[2] or Cardiac Resynchronization Therapy (CRT)[3] (Class I, IIa, or IIb indication).
  2. Patients with an existing pacemaker, ICD, or CRT device or leads.

  3. 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.

  4. 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.

  5. 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.

  6. Patient with any evidence of active infection or undergoing treatment for an infection.
  7. Patient is contraindicated from temporary suspension of oral/systemic anticoagulation.
  8. Patient with current implantation of neurostimulator or any other chronically implanted device that delivers current in the body.
  9. Patient meets ACC/AHA/HRS or ESC clinical guideline Class III criteria for an ICD (e.g., life expectancy of less than 12 months).
  10. 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.
  11. Patient with any exclusion criteria as required by local law (e.g., age or other).
  12. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Patients will be implanted with an Extravascular ICD and undergo requisite electrical testing.
Device: Defibrillation using the Extravascular ICD
VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: Through study completion, an average of 18 months
EV ICD system and/or procedure related adverse events
Through study completion, an average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

July 28, 2023

Study Completion (Anticipated)

July 28, 2023

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 20, 2021

Study Record Updates

Last Update Posted (Actual)

September 10, 2022

Last Update Submitted That Met QC Criteria

September 6, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT20054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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