Tachycardia, Ventricular Arrythmia
Conditions
Brief summary
The study is designed to characterize the acute safety and performance of the EV ICD System for Japanese patients.
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
* 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
Exclusion criteria
* 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: * Hiatal hernia that distorts mediastinal anatomy * Marked sternal abnormality (e.g., pectus excavatum) * Decompensated heart failure * COPD with oxygen dependence * Gross hepatosplenomegaly Or any other known medical condition or anatomy type not listed that precludes their participation in the opinion of the Investigator. * Patients with a medical condition that precludes them from undergoing defibrillation testing: * Severe aortic stenosis * Intracardiac LA or LV thrombus * Severe proximal three-vessel or left main coronary artery disease without revascularization * Hemodynamic instability * Unstable angina * Recent stroke or transient ischemic attack (within the last 6 months) * Known inadequate external defibrillation * LVEF \<20% * LVEDD \>70 mm Or any other known medical condition not listed that precludes their participation in the opinion of the Investigator. * Patient with any evidence of active infection or undergoing treatment for an infection. * Patient is contraindicated from temporary suspension of oral/systemic anticoagulation * Patient with current implantation of neurostimulator or any other chronically implanted device that delivers current in the body. * Patient meets ACC/AHA/HRS or ESC clinical guideline Class III criteria for an ICD (e.g., life expectancy of less than 12 months). * Patient is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager. * Patient with any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 2 Weeks Post-implant | 2 weeks (14 days) post-implant | The 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 2 weeks (14 days) post-implant. |
| Efficacy Outcome - Defibrillation Efficacy at Implant of the EV ICD System | At Implant | 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. |
Countries
Japan
Participant flow
Recruitment details
The first site was activated on 20JAN2023. The first EV ICD Japan subject was enrolled on 22FEB2023 and implanted on 01 MAR 2023. The last subject enrollment occurred on 27SEP2023, and the last implant occurred on 03OCT2023. Sites were notified of enrollment completion on 01DEC2023.
Participants by arm
| Arm | Count |
|---|---|
| Implant Attempt EV ICD Japan Subjects undergoing an implant attempt of an Extravascular ICD System, including implant testing (sensing, impedance and pacing testing) and induction and defibrillation testing using the Extravascular ICD. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Implant Attempt EV ICD Japan |
|---|---|
| Age, Continuous | 53.6 years STANDARD_DEVIATION 14.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 10 / 14 |
| serious Total, serious adverse events | 5 / 14 |
Outcome results
Primary
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.
Time frame: At Implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implant Attempt | Efficacy Outcome - Defibrillation Efficacy at Implant of the EV ICD System | 14 Participants |
Comparison: The primary efficacy objective was to characterize the defibrillation efficacy at implant of the EV ICD System.descriptive statistics
Primary
Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 2 Weeks Post-implant
The 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 2 weeks (14 days) post-implant.
Time frame: 2 weeks (14 days) post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implant Attempt | Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 2 Weeks Post-implant | 13 Participants |
Comparison: The first primary objective is to characterize the freedom from major complications related to the EV ICD System and/or procedure at 2 weeks post-implant. The 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 2 weeks (14 days) post-implant.descriptive statistics