Extravascular ICD Pivotal Study (EV ICD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 393
- 试验地点
- 108
- 主要终点
- Efficacy Outcome - Defibrillation Efficacy at Implant of the EV ICD System
研究概览
简要总结
Pivotal Summary:
The study is designed to demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.
Continued Access Summary:
This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.
详细描述
The study will enroll subjects who are indicated to receive an implantable defibrillator and who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will receive an investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver defibrillation therapy. Subjects will be followed until regulatory approval is received.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pivotal 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
排除标准
- •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 exclusion criteria as required by local law (e.g., age or other).
- •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.
- •[iii] 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing). [iv] ACC/AHA/HRS guidelines for Cardiac Resynchronization Therapy. [v] As documented on echo or MRI. [vi] As documented on CT scan or MRI.
- •Continued Access 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 for their participation in the study.
- •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, Granger CB, Hammill SC, Hlatky MA, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2018 Oct 2;72(14):e91-e
- •doi: 10.1016/j.jacc.2017.10.
- •Epub 2018 Aug
- •Review. Erratum in: J Am Coll Cardiol. 2018 Oct 2;72(14):
- •Continued Access Exclusion Criteria
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结局指标
主要结局
Efficacy Outcome - Defibrillation Efficacy at Implant of the EV ICD System
时间窗: 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.
Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 6 Months Post-implant
时间窗: 6 Months (182 days) post implant
The primary safety 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 6 months (182 days) post-implant.
次要结局
未报告次要终点