Chronic Evaluation of Novel Pacemaker System

Launched by CALYAN TECHNOLOGIES · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial, called the Chronic Evaluation of Novel Pacemaker System, is looking at a new device called the Calyan Pacemaker. The main goal is to see if this pacemaker is safe to use and if it works well for people who need help with their heart's rhythm, especially those who experience slow heart rates or bradycardia.

To participate in this trial, you need to be at least 18 years old and able to give consent. You should also have a medical reason for needing a single-chamber ventricular pacemaker, and your overall health should allow for a life expectancy of at least one year. However, certain conditions might prevent you from joining, such as having specific heart issues, prior heart surgeries, or infections. This trial is not currently recruiting participants, but when it does start, those eligible can expect to help researchers learn more about this new pacemaker system and its potential benefits for heart health.

Gender

ALL

Eligibility criteria

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