Chronic Evaluation of Novel Pacemaker System

The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.

Study Overview

• Status: Not yet recruiting
• Conditions: Bradycardia; Ventricular Pacing With Rate Response
• Intervention / Treatment: Device: Calyan Pacemaker

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imad Libbus, PhD; Phone Number: 763-657-1480; Email: imad@calyantech.com

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment; Chronic implantation of the Calyan pacemaker device

Device: Calyan 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of procedure and device related serious adverse events (SAEs)	Rate of procedure and device related serious adverse events (SAEs) at 3 months post-implant.	3 months
Number of patients with successful chronic ventricular pacing	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.	3 months

Collaborators and Investigators

• Sponsor: Calyan Technologies
• Investigators: Study Director: Imad Libbus, PhD, Calyan Technologies

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: CT-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes