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Not yet recruiting NCT06056817

Chronic Evaluation of Novel Pacemaker System

No phase Interventional Ventricular Pacing With Rate Response Bradycardia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Calyan Pacemaker.
Who it may be relevant to
Registry conditions: Ventricular Pacing With Rate Response, Bradycardia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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 Blueto

Primary outcome measures

  • Incidence of procedure and device related serious adverse events (SAEs) [Time frame: 3 months]
  • Number of patients with successful chronic ventricular pacing [Time frame: 3 months]

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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT06056817 · CT-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗