Chronic Evaluation of Novel Pacemaker System

Inclusion Criteria

• Age 18 or above
• Willing and capable of providing informed consent
• Class I or IIa indication for implantation of a single-chamber ventricular pacemaker, according to ACC/AHA/HRS guidelines
• A life expectancy of at least one year, and is a suitable candidate based on overall health and well-being

Exclusion Criteria

• Patients with complete AV block or other pacemaker-dependent conditions
• Patients in whom a substernal device implant should be avoided:

• Any prior sternotomy;
• Any prior medical condition or procedure that leads to adhesions in the anterior mediastinal space;
• Any marked sternal abnormality, such as pectus excavatum or pectus carinatum
• Prior abdominal surgery in the epigastric region
• Planned sternotomy
• Prior or planned chest radiotherapy
• Hiatal hernia that distorts mediastinal anatomy
• Adhesions in the anterior mediastinal space
• Severe obesity so that subxiphoid/substernal tunneling cannot be safely performed
• Patients with severe RV dilation, gross hepatosplenomegaly, or severe obesity such that subxiphoidal/substernal tunneling cannot be safely performed
• Patients with a class III indication for a permanent pacemaker
• Patients with decompensated heart failure not due to bradycardia and expected to worsen with chronic RV pacing
• 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
• 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
• Patients who have previously undergone an open-heart surgical procedure.
• Patients with an active infection
• Patient on chronic oral anticoagulation which cannot be temporarily discontinued for surgery
• 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
• Patients who have tested positive for the COVID-19 in the past 3 months, or are currently showing symptoms consistent with COVID-19
• Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding
• Subjects with a life expectancy of less than 12 months
• Patients who are currently enrolled or planning to participate in any concurrent clinical study with an investigational therapy
• Patients with decompensated heart failure expected to worsen with chronic RV pacing
• Patients with COPD with oxygen dependence