Chronic Evaluation of Novel Pacemaker System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventricular Pacing With Rate Response
- Sponsor
- Calyan Technologies
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Incidence of procedure and device related serious adverse events (SAEs)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Incidence of procedure and device related serious adverse events (SAEs)
Time Frame: 3 months
Rate of procedure and device related serious adverse events (SAEs) at 3 months post-implant.
Number of patients with successful chronic ventricular pacing
Time Frame: 3 months
Proportion of patients with successful chronic ventricular pacing, including successful pacemaker implantation and chronic capture of the ventricle, during the 3-month primary follow-up period.