Extravascular ICD Pivotal Study

NCT04060680 | Completed Results DMC FDA Device

• 2 other identifiers: U1111-1236-4810MDT16028
• Study Type: interventional
• Target: 393
• Locations: 16 countries
• Sites: 55

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.

Conditions

Tachycardia; Ventricular Arrythmia

Outcome Measures

Primary Outcomes (2)

• Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 6 Months 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.

  6 Months (182 days) post implant

• Efficacy Outcome - Defibrillation Efficacy at Implant of the EV ICD System

  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.

  At Implant

Study Arms (2)

Implant Attempt

EXPERIMENTAL

Patients will be implanted with an extravascular ICD and undergo requisite electrical testing.

Device: Defibrillation using the Extravascular ICD

Continued Access Implant Attempt

EXPERIMENTAL

Continued Access for United States

Device: Defibrillation using the Extravascular ICD

Interventions

Defibrillation using the Extravascular ICD DEVICE

VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.

Continued Access Implant Attempt; Implant Attempt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (56)

HonorHealth Cardiac Arrhythmia Group - Osborn

Scottsdale, Arizona, 85258, United States

Location

University of California San Diego (UCSD)

La Jolla, California, 92093, United States

Location

Continued Access: Sequoia Hospital

Redwood City, California, 94062, United States

Location

Sequoia Hospital

Redwood City, California, 94062, United States

Location

Continued Access: Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MedStar Wahsington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Baptist Health

Jacksonville, Florida, 32216, United States

Location

Continued Access: Baptist Health

Jacksonville, Florida, 32216, United States

Location

AdventHealth Cardiovascular Research Institute

Orlando, Florida, 32803, United States

Location

Northwestern University

Chicago, Illinois, 60611-2969, United States

Location

Prairie Education & Research Cooperative

Springfield, Illinois, 62769, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50266, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Continued Access: University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455-0363, United States

Location

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455-0363, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Continued Access: Saint Luke's Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Saint Luke's Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07960, United States

Location

Continued Access: Lourdes Cardiology Services

Voorhees Township, New Jersey, 08043, United States

Location

Lourdes Cardiology Services

Voorhees Township, New Jersey, 08043, United States

Location

Continued Access: North Shore University Hospital

Manhasset, New York, 11030, United States

Location

North Shore Uniersity Hospital

Manhasset, New York, 11030, United States

Location

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10065-4870, United States

Location

Continued Access: New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Duke University Medical Center (DUMC)

Durham, North Carolina, 27705, United States

Location

Continued Access: University Hospitals Cleveland Clinic Medical Center

Cleveland, Ohio, 44106, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Continued Access: OhioHealth Research and Innovation Institute (OHRI)

Columbus, Ohio, 43214, United States

Location

OhioHealth Research and Innovation Institute (OHRI)

Columbus, Ohio, 43214, United States

Location

University of Washington (UW) Medical Center

Seattle, Washington, 98195, United States

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Monash Medical Centre Clayton

Clayton, Victoria, 3168, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Kepler Universitätsklinikum Med Campus III.

Linz, Austria

Location

London Health Sciences Centre - University Campus

London, N6A 5A5, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, G1V 4G5, Canada

Location

Odense Universitetshospital

Odense, 5000, Denmark

Location

CHRU de Tours - Hôpital Trousseau

Chambray-lès-Tours, 37170, France

Location

CHU de Rennes - Hôpital Pontchaillou

Rennes, 35033, France

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Semmelweis Egyetem AOK

Budapest, Hungary

Location

Policlinico Sant' Orsola - Malpighi

Bologna, 40138, Italy

Location

Amsterdam UMC - Locatie AMC

Amsterdam, 1105 AZ, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Isala Zwolle

Zwolle, 8025 AB, Netherlands

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Oslo Universitetssykehus-Rikshospitalet

Oslo, 0027, Norway

Location

Narodowy Instytut Kardiologii - Stefana kardynała Wyszyńskiego

Warsaw, 04-628, Poland

Location

The College of Medicine & King Khalid University Hospital, King Saud University

Riyadh, 11472, Saudi Arabia

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

UniversitätsSpital Zürich

Zurich, 8091, Switzerland

Location

King's College of London

London, WC2R 2LS, United Kingdom

Location

Related Publications (4)

• Friedman P, Murgatroyd F, Boersma LVA, Manlucu J, Knight BP, Clementy N, Leclercq C, Amin A, Merkely B, Birgersdotter-Green UM, Chan JYS, Biffi M, Knops RE, Engel G, Munoz Carvajal I, Epstein LM, Sagi V, Johansen JB, Sterlinski M, Steinwender C, Hounshell T, Abben R, Thompson AE, Zhang Y, Wiggenhorn C, Willey S, Crozier I; Extravascular ICD Pivotal Study Investigators. Performance and Safety of the Extravascular Implantable Cardioverter Defibrillator Through Long-Term Follow-Up: Final Results From the Pivotal Study. Circulation. 2025 Jan 28;151(4):322-332. doi: 10.1161/CIRCULATIONAHA.124.071795. Epub 2024 Sep 26.

  PMID: 39327797 DERIVED

• Swerdlow C, Gillberg J, Boersma LVA, Manlucu J, Zhang X, Zhang Y, Hernandez AA, Bhatia V, Murgatroyd F. Extravascular Implantable Cardioverter-Defibrillator Sensing and Detection in a Large Global Population. JACC Clin Electrophysiol. 2024 Aug;10(8):1896-1912. doi: 10.1016/j.jacep.2024.02.033. Epub 2024 May 15.

  PMID: 38752961 DERIVED

• Friedman P, Murgatroyd F, Boersma LVA, Manlucu J, O'Donnell D, Knight BP, Clementy N, Leclercq C, Amin A, Merkely BP, Birgersdotter-Green UM, Chan JYS, Biffi M, Knops RE, Engel G, Munoz Carvajal I, Epstein LM, Sagi V, Johansen JB, Sterlinski M, Steinwender C, Hounshell T, Abben R, Thompson AE, Wiggenhorn C, Willey S, Crozier I; Extravascular ICD Pivotal Study Investigators. Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator. N Engl J Med. 2022 Oct 6;387(14):1292-1302. doi: 10.1056/NEJMoa2206485. Epub 2022 Aug 28.

  PMID: 36036522 DERIVED

• Crozier I, O'Donnell D, Boersma L, Murgatroyd F, Manlucu J, Knight BP, Birgersdotter-Green UM, Leclercq C, Thompson A, Sawchuk R, Willey S, Wiggenhorn C, Friedman P. The extravascular implantable cardioverter-defibrillator: The pivotal study plan. J Cardiovasc Electrophysiol. 2021 Sep;32(9):2371-2378. doi: 10.1111/jce.15190. Epub 2021 Aug 5.

  PMID: 34322918 DERIVED

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Drew Turk, Clinical Research Specialist
• Organization: Medtronic

drew.turk@medtronic.com

7633580375

Study Officials

• Paul Friedman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 19, 2019
• Study Start: September 16, 2019
• Primary Completion: April 28, 2022
• Study Completion: January 4, 2024
• Last Updated: November 19, 2024
• Results First Posted: July 3, 2023

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); DK (1); NL (3); NO (1); IT (1); SA (1); NZ (1); ES (1); AU (4); CH (1); CA (2); HK (1); PL (1); HU (1); US (33); FR (2)