Chronic Evaluation of Novel Pacemaker System
Calyan Technologies
Summary
The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.
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 implanted, and if acute success criteria are met, chronic pacing will be delivered over a 3-month primary follow-up period, with subsequent extended follow-up of all patients. The data from this study will be used to justify the design of a larger prospective pivotal study that will assess the safety and effectiveness of the Calyan pacemaker device.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 a…
Interventions
- DeviceCalyan Pacemaker
The Calyan pacemaker is a device designed for implantation in the chest below the xiphoid process, and includes a FlexArm containing stimulation and sensing electrodes. The Calyan pacemaker is implanted using a set of delivery tools and clipped onto the xiphoid process; the FlexArm electrodes are oriented to make contact with the pericardial surface of the heart. Pacing parameters are adjusted wirelessly with a tablet-based programmer that communicates with the Calyan pacemaker via secure Bluetooth.
Location
- University of MinnesotaMinneapolis, Minnesota