Extravascular ICD Pivotal Study

Not Applicable

Completed

Conditions: Ventricular Arrythmia
Tachycardia

Interventions: Device: Defibrillation using the Extravascular ICD

Registration Number: NCT04060680

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary: Pivotal Summary:

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

Continued Access Summary:

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

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 until regulatory approval is received.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 393

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

Pivotal

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.

Continued Access Inclusion Criteria

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.

[1] 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. Review. Erratum in: J Am Coll Cardiol. 2018 Oct 2;72(14):1760.

Continued Access Exclusion Criteria

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
- 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)

[2] 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. [3] 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. Erratum in: J Am Coll Cardiol. 2019 Aug 20;74(7):1016-1018.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implant Attempt	Defibrillation using the Extravascular ICD	Patients will be implanted with an extravascular ICD and undergo requisite electrical testing.

Primary Outcome Measures

Name	Time	Method
Efficacy Outcome - Defibrillation Efficacy at Implant of the EV ICD System	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.
Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 6 Months Post-implant	6 Months (182 days) post implant	The primary safety 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 6 months (182 days) post-implant.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (56): Continued Access: OhioHealth Research and Innovation Institute (OHRI)
🇺🇸
Columbus, Ohio, United States
OhioHealth Research and Innovation Institute (OHRI)
🇺🇸
Columbus, Ohio, United States
St. Antonius Ziekenhuis
🇳🇱
Nieuwegein, Netherlands
University Hospitals Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
Semmelweis Egyetem AOK
🇭🇺
Budapest, Hungary
Isala Zwolle
🇳🇱
Zwolle, Netherlands
Minneapolis Heart Institute Foundation
🇺🇸
Minneapolis, Minnesota, United States
Continued Access: University of Minnesota Medical Center Fairview
🇺🇸
Minneapolis, Minnesota, United States
University of Minnesota Medical Center Fairview
🇺🇸
Minneapolis, Minnesota, United States
Continued Access: Sequoia Hospital
🇺🇸
Redwood City, California, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
🇺🇸
New York, New York, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Kepler Universitätsklinikum Med Campus III.
🇦🇹
Linz, Austria
HonorHealth Cardiac Arrhythmia Group - Osborn
🇺🇸
Scottsdale, Arizona, United States
University of California San Diego (UCSD)
🇺🇸
La Jolla, California, United States
Baptist Health
🇺🇸
Jacksonville, Florida, United States
Continued Access: Medstar Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
MedStar Wahsington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Sequoia Hospital
🇺🇸
Redwood City, California, United States
Continued Access: Baptist Health
🇺🇸
Jacksonville, Florida, United States
Iowa Heart Center
🇺🇸
Des Moines, Iowa, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Prairie Education & Research Cooperative
🇺🇸
Springfield, Illinois, United States
Cardiovascular Institute of the South
🇺🇸
Houma, Louisiana, United States
Morristown Memorial Hospital
🇺🇸
Morristown, New Jersey, United States
Continued Access: Lourdes Cardiology Services
🇺🇸
Voorhees, New Jersey, United States
Lourdes Cardiology Services
🇺🇸
Voorhees, New Jersey, United States
North Shore Uniersity Hospital
🇺🇸
Manhasset, New York, United States
Continued Access: North Shore University Hospital
🇺🇸
Manhasset, New York, United States
Continued Access: New York-Presbyterian Hospital/Weill Cornell Medical Center
🇺🇸
New York, New York, United States
Duke University Medical Center (DUMC)
🇺🇸
Durham, North Carolina, United States
Continued Access: University Hospitals Cleveland Clinic Medical Center
🇺🇸
Cleveland, Ohio, United States
Westmead Hospital
🇦🇺
Westmead, New South Wales, Australia
University of Washington (UW) Medical Center
🇺🇸
Seattle, Washington, United States
Royal Adelaide Hospital
🇦🇺
Adelaide, South Australia, Australia
Monash Medical Centre Clayton
🇦🇺
Clayton, Victoria, Australia
Austin Hospital
🇦🇺
Heidelberg, Victoria, Australia
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
🇨🇦
Québec, Canada
London Health Sciences Centre - University Campus
🇨🇦
London, Canada
Odense Universitetshospital
🇩🇰
Odense, Denmark
CHRU de Tours - Hôpital Trousseau
🇫🇷
Chambray-lès-Tours, France
Prince of Wales Hospital
🇭🇰
Hong Kong, Hong Kong
Policlinico Sant' Orsola - Malpighi
🇮🇹
Bologna, Italy
CHU de Rennes - Hôpital Pontchaillou
🇫🇷
Rennes, France
Amsterdam UMC - Locatie AMC
🇳🇱
Amsterdam, Netherlands
Oslo Universitetssykehus-Rikshospitalet
🇳🇴
Oslo, Norway
Hospital Universitario Reina Sofía
🇪🇸
Córdoba, Spain
Narodowy Instytut Kardiologii - Stefana kardynała Wyszyńskiego
🇵🇱
Warszawa, Poland
Christchurch Hospital
🇳🇿
Christchurch, New Zealand
The College of Medicine & King Khalid University Hospital, King Saud University
🇸🇦
Riyadh, Saudi Arabia
King's College of London
🇬🇧
London, United Kingdom
UniversitätsSpital Zürich
🇨🇭
Zürich, Switzerland
AdventHealth Cardiovascular Research Institute
🇺🇸
Orlando, Florida, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Continued Access: Saint Luke's Mid America Heart Institute
🇺🇸
Kansas City, Missouri, United States
Saint Luke's Mid America Heart Institute
🇺🇸
Kansas City, Missouri, United States