Extravascular ICD Pilot Study

Not Applicable

Completed

Conditions: Tachycardia
Ventricular Arrythmia

Interventions: Device: Defibrillation using the Extravascular ICD

Registration Number: NCT03608670

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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

Detailed Description: The study will recruit male and female adult subjects that meet all of the inclusion criteria and none of the exclusion criteria. All subjects will be indicated to receive an ICD.

The EV ICD system will be implanted and the subjects will be followed for at least 3 months following implantation of the system.

Subjects will be exited after follow-up is completed.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 26

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.
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

Exclusion Criteria

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

• Resulted in pericardial effusion [5], or

• Resulted in pericardial thickening or calcification [6]
Patients with a medical condition that precludes them from undergoing defibrillation testing, such as:

• known LV thrombus

• decompensated heart failure
- LVEF <20% [7]
- other physician discretion
Patient has persistent Atrial Fibrillation who is at high risk of a thromboembolic event with a CHA₂DS₂-VASc score ≥3, or is contraindicated for having anticoagulation interrupted for ≥72 hours
Patients with comorbidities which may increase surgical risk of complications[8] including:

• severe aortic stenosis
- COPD and is oxygen dependent
- Hepatosplenomegaly
- Marked hepatomegaly
Patient is on renal dialysis
Patient with any evidence of active infection or undergoing treatment for an infection
Patient with current implantation of neurostimulator or any other chronically implanted device which uses current in the body.
Patients with a limited life expectancy of less than 12 months
Patient is enrolled or planning to enroll in a concurrent drug or device 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, pregnancy, breast feeding)
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 [9]

[1] 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing).

[2] ACC/AHA/HRS guidelines for Cardiac Resynchronization Therapy [3] Per physician discretion [4] BMI > 40 [5] As documented on echo or MRI [6] As documented on CT scan or MRI [7] Most recent LVEF in the last 180 days (inclusive) [8] Per physician discretion [9] if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to EV ICD Pilot Study procedures

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	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 - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation	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.
Safety Outcome - Percentage of Participants With Freedom From Major System and Procedure Related Complications at 3 Months (90 Days)	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (4): The Prince Charles Hospital
🇦🇺
Brisbane, Australia
Christchurch Hospital
🇳🇿
Christchurch, New Zealand
MonashHeart
🇦🇺
Clayton, Australia
Austin Health
🇦🇺
Heidelberg, Australia