Ensayos clínicos

Inclusion Criteria:

• Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines, or ESC guidelines. 
• 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.

Exclusion Criteria: 

• Patient is unwilling or unable to personally provide Informed Consent. 
• Patient has indications for bradycardia pacing or Cardiac Resynchronization Therapy (CRT) (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; or
  • Resulted in pericardial thickening or calcification. 
• 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.