EV ICD: Extravascular ICD Pilot Study
Study Details
Study Description
Brief Summary
The proposed study is designed to characterize the safety and efficacy of a new extravascular implantable cardioverter defibrillator (ICD) system in humans.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
-
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The Prince Charles Hospital | Brisbane | Australia | ||
2 | MonashHeart | Clayton | Australia | ||
3 | Austin Health | Heidelberg | Australia | ||
4 | Christchurch Hospital | Christchurch | New Zealand |
Sponsors and Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
Investigators
- Principal Investigator: Ian G Crozier, MB ChB, Christchurch Hospital, Christchurch, New Zealand
Study Documents (Full-Text)
More Information
Publications
None provided.- MDT17034
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | 26 participants consented and enrolled into the protocol. 5 participants were exited prior to an implant attempt. |
Arm/Group Title | Experimental |
---|---|
Arm/Group Description | Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing. Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing. |
Period Title: Overall Study | |
STARTED | 26 |
Implant Attempted | 21 |
Successfully Implanted | 17 |
2-week Follow-up | 17 |
4-6 Weeks Follow-up | 17 |
COMPLETED | 16 |
NOT COMPLETED | 10 |
Baseline Characteristics
Arm/Group Title | Experimental |
---|---|
Arm/Group Description | Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing. Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing. |
Overall Participants | 26 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
55.4
(13.0)
|
Sex: Female, Male (Count of Participants) | |
Female |
4
15.4%
|
Male |
22
84.6%
|
Race/Ethnicity, Customized (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
0
0%
|
Black or African American |
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
White or Caucasian |
22
84.6%
|
Other: Maori |
2
7.7%
|
Other: Macedonian |
1
3.8%
|
Other: Afghani |
1
3.8%
|
ICD Indication (Count of Participants) | |
Class I indication: Cardiac arrest due to VF/hemodynamically unstable sustained VT |
4
15.4%
|
Class I indication: Structural heart disease and spontaneous sustained VT |
1
3.8%
|
Class I indication: LVEF ≤ 35% due to prior MI, NYHA Class II or III |
5
19.2%
|
Class I indication: Nonischemic dilated cardiomyopathy, LVEF ≤ 35%, NYHA Class II or III |
5
19.2%
|
Class IIa indication: LV dysfunction due to prior MI, LVEF ≤ 30%, NYHA Class I |
3
11.5%
|
Class I Indication: Hypertrophic cardiomyopathy, 1 or more major risk factors for SCD |
6
23.1%
|
Class I Indication: Arrhythmogenic RV dysplasia / cardiomyopathy, ≥ 1 risk factor for SCD |
1
3.8%
|
Class IIb indication: Nonischemic heart disease, LVEF ≤ 35%, NYHA functional Class I |
1
3.8%
|
Outcome Measures
Title | Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation |
---|---|
Description | 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. |
Time Frame | At Implantation |
Outcome Measure Data
Analysis Population Description |
---|
Number of participants who underwent and completed the defibrillation testing protocol. |
Arm/Group Title | Experimental |
---|---|
Arm/Group Description | Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing. Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing. |
Measure Participants | 20 |
Count of Participants [Participants] |
18
69.2%
|
Title | Safety Outcome - Percentage of Participants With Freedom From Major System and Procedure Related Complications at 3 Months (90 Days) |
---|---|
Description | Subjects will be monitored to determine whether they experience a major procedure- or system-related complication within 3 months (90 days) post-implant. |
Time Frame | 3 months (90 days) |
Outcome Measure Data
Analysis Population Description |
---|
All participants for whom an implant of the investigational product was attempted were included in the analysis |
Arm/Group Title | Experimental |
---|---|
Arm/Group Description | Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing. Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing. |
Measure Participants | 21 |
Number (95% Confidence Interval) [percentage of participants] |
94.1
361.9%
|
Adverse Events
Time Frame | Assessed from Implant visit through to 3 Months (90 days inclusive) | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Experimental | |
Arm/Group Description | Patients enrolled to receive an extravascular ICD and undergo requisite electrical testing. Defibrillation using the Extravascular ICD: VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing. | |
All Cause Mortality |
||
Experimental | ||
Affected / at Risk (%) | # Events | |
Total | 0/21 (0%) | |
Serious Adverse Events |
||
Experimental | ||
Affected / at Risk (%) | # Events | |
Total | 5/21 (23.8%) | |
Gastrointestinal disorders | ||
Constipation | 1/21 (4.8%) | 1 |
Nervous system disorders | ||
Migraine | 1/21 (4.8%) | 1 |
Product Issues | ||
Lead dislodgement | 2/21 (9.5%) | 2 |
Renal and urinary disorders | ||
Urinary retention | 1/21 (4.8%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Chronic obstructive pulmonary disease | 1/21 (4.8%) | 1 |
Vascular disorders | ||
Orthostatic hypotension | 1/21 (4.8%) | 2 |
Other (Not Including Serious) Adverse Events |
||
Experimental | ||
Affected / at Risk (%) | # Events | |
Total | 8/21 (38.1%) | |
Cardiac disorders | ||
Ventricular tachycardia | 1/21 (4.8%) | 2 |
Atrial tachycardia | 1/21 (4.8%) | 1 |
Palpitations | 1/21 (4.8%) | 1 |
General disorders | ||
Fatigue | 1/21 (4.8%) | 1 |
Implant site swelling | 1/21 (4.8%) | 1 |
Impaired healing | 1/21 (4.8%) | 1 |
Chest pain | 1/21 (4.8%) | 1 |
Infections and infestations | ||
Postoperative wound infection | 1/21 (4.8%) | 1 |
Nervous system disorders | ||
Lethargy | 1/21 (4.8%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Pleuritic pain | 2/21 (9.5%) | 2 |
Vascular disorders | ||
Hypotension | 1/21 (4.8%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | CRM Clinical Research |
---|---|
Organization | Medtronic Cardiac Rhythm Management |
Phone | +1 800 328 2518 |
rs.medtronicCRMtrials@medtronic.com |
- MDT17034