Tachycardia, Ventricular Arrythmia
Conditions
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.
Interventions
VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines\[1\] 2. Patient is willing and able to sign and date the Informed Consent Form. 3. Patient is at least 18 years of age and meets age requirements per local law 4. 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
1. Patient has indications for bradycardia pacing \[1\] or Cardiac Resynchronization Therapy (CRT) \[2\] (Class I, IIa, or IIb indication) 2. Patient has an existing or had a prior pacemaker, ICD, or CRT device implant or leads 3. 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 4. Patient has prior chest radiotherapy 5. Patient had previous mediastinitis 6. Patient had previous coronary artery bypass grafting procedure 7. Patient has existing transcatheter aortic valve replacement 8. Patient has gastrostomy tube 9. Patient has had a prior sternotomy, prior mediastinal instrumentation, prior abdominal surgery in the epigastric region, or planned sternotomy 10. Patient has previous pericarditis that: • Was chronic and recurrent, or • Resulted in pericardial effusion \[5\], or • Resulted in pericardial thickening or calcification \[6\] 11. 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 12. 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 13. Patients with comorbidities which may increase surgical risk of complications\[8\] including: • severe aortic stenosis * COPD and is oxygen dependent * Hepatosplenomegaly * Marked hepatomegaly 14. Patient is on renal dialysis 15. Patient with any evidence of active infection or undergoing treatment for an infection 16. Patient with current implantation of neurostimulator or any other chronically implanted device which uses current in the body. 17. Patients with a limited life expectancy of less than 12 months 18. 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 19. Patient with any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, New Zealand
Participant flow
Pre-assignment details
26 participants consented and enrolled into the protocol. 5 participants were exited prior to an implant attempt.
Participants by arm
| Arm | Count |
|---|---|
| Experimental 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. | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Experimental |
|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 13 |
| ICD Indication Class IIa indication: LV dysfunction due to prior MI, LVEF ≤ 30%, NYHA Class I | 3 Participants |
| ICD Indication Class IIb indication: Nonischemic heart disease, LVEF ≤ 35%, NYHA functional Class I | 1 Participants |
| ICD Indication Class I Indication: Arrhythmogenic RV dysplasia / cardiomyopathy, ≥ 1 risk factor for SCD | 1 Participants |
| ICD Indication Class I indication: Cardiac arrest due to VF/hemodynamically unstable sustained VT | 4 Participants |
| ICD Indication Class I Indication: Hypertrophic cardiomyopathy, 1 or more major risk factors for SCD | 6 Participants |
| ICD Indication Class I indication: LVEF ≤ 35% due to prior MI, NYHA Class II or III | 5 Participants |
| ICD Indication Class I indication: Nonischemic dilated cardiomyopathy, LVEF ≤ 35%, NYHA Class II or III | 5 Participants |
| ICD Indication Class I indication: Structural heart disease and spontaneous sustained VT | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other: Afghani | 1 Participants |
| Race/Ethnicity, Customized Other: Macedonian | 1 Participants |
| Race/Ethnicity, Customized Other: Maori | 2 Participants |
| Race/Ethnicity, Customized White or Caucasian | 22 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 8 / 21 |
| serious Total, serious adverse events | 5 / 21 |
Outcome results
Primary
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.
Time frame: At Implantation
Population: Number of participants who underwent and completed the defibrillation testing protocol.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental | Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation | 18 Participants |
Primary
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.
Time frame: 3 months (90 days)
Population: All participants for whom an implant of the investigational product was attempted were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental | Safety Outcome - Percentage of Participants With Freedom From Major System and Procedure Related Complications at 3 Months (90 Days) | 94.1 percentage of participants |