Extravascular ICD Pilot Study

NCT03608670 | Completed Results DMC FDA Device

• 1 other identifier: MDT17034
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 4

Brief Summary

The proposed study is designed to characterize the safety and efficacy of a new extravascular implantable cardioverter defibrillator (ICD) system in humans.

Conditions

Tachycardia; Ventricular Arrythmia

Outcome Measures

Primary Outcomes (2)

• Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation

  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 5 such episodes may be induced to test device efficacy.

  At Implantation

• Safety Outcome - Percentage of Participants With Freedom From Major System and Procedure Related Complications at 3 Months (90 Days)

  Subjects will be monitored to determine whether they experience a major procedure- or system-related complication within 3 months (90 days) post-implant.

  3 months (90 days)

Study Arms (1)

Experimental

EXPERIMENTAL

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

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.

Experimental

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\[1\]
• Patient is willing and able to sign and date the Informed Consent Form.
• 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, 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

You may not qualify if:

• Patient has indications for bradycardia pacing \[1\] or Cardiac Resynchronization Therapy (CRT) \[2\] (Class I, IIa, or IIb indication)
• Patient has an existing or had a prior pacemaker, ICD, or CRT device implant or leads
• Patient has anatomical abnormality that significantly increases implant risk\[3\] including:
• Severe obesity \[4\]
• Marked RV dilation
• Marked sternal abnormality
• Hiatus hernia that distorts mediastinal anatomy
• Patient has prior chest radiotherapy
• Patient had previous mediastinitis
• Patient had previous coronary artery bypass grafting procedure
• Patient has existing transcatheter aortic valve replacement
• Patient has gastrostomy tube
• Patient has had a prior sternotomy, prior mediastinal instrumentation, prior abdominal surgery in the epigastric region, or planned sternotomy
• Patient has previous pericarditis that:
• Was chronic and recurrent, or

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (4)

The Prince Charles Hospital

Brisbane, Australia

Location

MonashHeart

Clayton, Australia

Location

Austin Health

Heidelberg, Australia

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Related Publications (1)

• Crozier I, Haqqani H, Kotschet E, Shaw D, Prabhu A, Roubos N, Alison J, Melton I, Denman R, Lin T, Almeida A, Portway B, Sawchuk R, Thompson A, Sherfesee L, Liang S, Lentz L, DeGroot P, Cheng A, O'Donnell D. First-in-Human Chronic Implant Experience of the Substernal Extravascular Implantable Cardioverter-Defibrillator. JACC Clin Electrophysiol. 2020 Nov;6(12):1525-1536. doi: 10.1016/j.jacep.2020.05.029. Epub 2020 Aug 26.

  PMID: 33213813 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: CRM Clinical Research
• Organization: Medtronic Cardiac Rhythm Management

rs.medtronicCRMtrials@medtronic.com

+1 800 328 2518

Study Officials

• Ian G Crozier, MB ChB

  Christchurch Hospital, Christchurch, New Zealand

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: August 1, 2018
• Study Start: July 17, 2018
• Primary Completion: March 11, 2019
• Study Completion: November 15, 2023
• Last Updated: January 8, 2024
• Results First Posted: April 22, 2022

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); AU (3)