Chronic Evaluation of Novel Pacemaker System

Exclusion Criteria

• •1. Patients with complete AV block or other pacemaker-dependent conditions
• •2. Patients in whom a substernal device implant should be avoided:
• •1. Any prior sternotomy;
• •2. Any prior medical condition or procedure that leads to adhesions in the anterior mediastinal space;
• •3. Any marked sternal abnormality, such as pectus excavatum or pectus carinatum
• •4. Prior abdominal surgery in the epigastric region
• •5. Planned sternotomy
• •6. Prior or planned chest radiotherapy
• •7. Hiatal hernia that distorts mediastinal anatomy
• •8. Adhesions in the anterior mediastinal space
• •9. Severe obesity so that subxiphoid/substernal tunneling cannot be safely performed
• •3. Patients with severe RV dilation, gross hepatosplenomegaly, or severe obesity such that subxiphoidal/substernal tunneling cannot be safely performed
• •4. Patients with a class III indication for a permanent pacemaker
• •5. Patients with decompensated heart failure not due to bradycardia and expected to worsen with chronic RV pacing
• •6. Patients with an implanted cardiac pacemaker, cardioverter defibrillator, cardiac resynchronization device, or neurostimulator device, or planned implantation of a cardioverter defibrillator, cardiac resynchronization device, or neurostimulator device
• •7. Patients with a current or planned implantation of a substernal device, or any implanted device that would interfere with the implantation or operation of a substernal device
• •8. Patients who have previously undergone an open-heart surgical procedure.
• •9. Patients with an active infection
• •10. Patient on chronic oral anticoagulation which cannot be temporarily discontinued for surgery
• •11. Patients with a condition in which pericardial pacing would be difficult or impossible, such as acute pericarditis, chronic pericardial effusion or pericardial thickening or calcification, cardiac tamponade, or chronic restrictive pericarditis
• •12. Patients who have tested positive for the COVID-19 in the past 3 months, or are currently showing symptoms consistent with COVID-19
• •13. Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding
• •14. Subjects with a life expectancy of less than 12 months
• •15. Patients who are currently enrolled or planning to participate in any concurrent clinical study with an investigational therapy
• •16. Patients with decompensated heart failure expected to worsen with chronic RV pacing
• •17. Patients with COPD with oxygen dependence