EV ICD: Extravascular ICD Pivotal Study

Sponsor

Medtronic Cardiac Rhythm and Heart Failure (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04060680

Collaborator

(none)

356

Enrollment

Locations

Arm

46.5

Anticipated Duration (Months)

7.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 using the Extravascular ICD	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

356 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Extravascular ICD Pivotal Study (EV ICD)

Actual Study Start Date :

Sep 16, 2019

Actual Primary Completion Date :

Apr 28, 2022

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Safety Outcome - Freedom from major complications related to the EV ICD System and/or procedure at 6 months post-implant [6 Months]
Subjects will be monitored to determine whether they experience a major procedure- or system-related complication within 6 months post-implant.
Efficacy Outcome - Defibrillation efficacy at implant of the EV ICD System [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HonorHealth Cardiac Arrhythmia Group - Osborn	Scottsdale	Arizona	United States	85258
2	University of California San Diego (UCSD)	La Jolla	California	United States	92093
3	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
4	Sequoia Hospital	Redwood City	California	United States	94062
5	MedStar Wahsington Hospital Center	Washington	District of Columbia	United States	20010
6	Baptist Health	Jacksonville	Florida	United States	32216
7	AdventHealth Cardiovascular Research Institute	Orlando	Florida	United States	32803
8	Northwestern University	Chicago	Illinois	United States	60611-2969
9	Prairie Education & Research Cooperative	Springfield	Illinois	United States	62769
10	Iowa Heart Center	Des Moines	Iowa	United States	50266
11	Cardiovascular Institute of the South	Houma	Louisiana	United States	70360
12	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	United States	55407
13	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota	United States	55455-0363
14	Mayo Clinic	Rochester	Minnesota	United States	55905
15	Saint Luke's Mid America Heart Institute	Kansas City	Missouri	United States	64111
16	Morristown Memorial Hospital	Morristown	New Jersey	United States	07960
17	Lourdes Cardiology Services	Voorhees	New Jersey	United States	08043
18	North Shore Uniersity Hospital	Manhasset	New York	United States	11030
19	New York-Presbyterian Hospital/Weill Cornell Medical Center	New York	New York	United States	10065-4870
20	Duke University Medical Center (DUMC)	Durham	North Carolina	United States	27705
21	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
22	Cleveland Clinic	Cleveland	Ohio	United States	44195
23	OhioHealth Research and Innovation Institute (OHRI)	Columbus	Ohio	United States	43214
24	University of Washington (UW) Medical Center	Seattle	Washington	United States	98195
25	Westmead Hospital	Westmead	New South Wales	Australia	2145
26	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
27	Monash Medical Centre Clayton	Clayton	Victoria	Australia	3168
28	Austin Hospital	Heidelberg	Victoria	Australia	3084
29	Kepler Universitätsklinikum Med Campus III.	Linz		Austria
30	University of Calgary	Calgary	Alberta	Canada	T2N 4N1
31	London Health Sciences Centre - University Campus	London		Canada	N6A 5A5
32	Royal Columbian Hospital	New Westminster		Canada	V3L 3W4
33	Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)	Québec		Canada	G1V 4G5
34	Odense Universitetshospital	Odense		Denmark	5000
35	CHRU de Tours - Hôpital Trousseau	Chambray-lès-Tours		France	37170
36	CHU de Rennes - Hôpital Pontchaillou	Rennes		France	35033
37	Prince of Wales Hospital	Hong Kong		Hong Kong
38	Semmelweis Egyetem AOK	Budapest		Hungary
39	Policlinico Sant' Orsola - Malpighi	Bologna		Italy	40138
40	Amsterdam UMC - Locatie AMC	Amsterdam		Netherlands	1105 AZ
41	St. Antonius Ziekenhuis	Nieuwegein		Netherlands	3435 CM
42	Isala Zwolle	Zwolle		Netherlands	8025 AB
43	Christchurch Hospital	Christchurch		New Zealand
44	Oslo Universitetssykehus-Rikshospitalet	Oslo		Norway	0027
45	Narodowy Instytut Kardiologii - Stefana kardynała Wyszyńskiego	Warszawa		Poland	04-628
46	The College of Medicine & King Khalid University Hospital, King Saud University	Riyadh		Saudi Arabia	11472
47	Hospital Universitario Reina Sofía	Córdoba		Spain	14004
48	UniversitätsSpital Zürich	Zürich		Switzerland	8091
49	King's College of London	London		United Kingdom	WC2R 2LS

Sponsors and Collaborators

Medtronic Cardiac Rhythm and Heart Failure

Investigators

Principal Investigator: Paul Friedman, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medtronic Cardiac Rhythm and Heart Failure

ClinicalTrials.gov Identifier:

NCT04060680

Other Study ID Numbers:

U1111-1236-4810
MDT16028

First Posted:

Aug 19, 2019

Last Update Posted:

Jun 6, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Tachycardia

Study Results

No Results Posted as of Jun 6, 2022