Status:
UNKNOWN
Chronic Evaluation of Novel Pacemaker System
Lead Sponsor:
Calyan Technologies
Conditions:
Ventricular Pacing With Rate Response
Bradycardia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.
Detailed Description
This is an early feasibility study, designed to evaluate the initial clinical safety, device functionality and stability and potential effectiveness of the Calyan pacemaker. The Calyan device will be ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06056817
Start Date
October 1 2024
End Date
March 31 2025
Last Update
August 20 2024
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455