Patient Preferences for Leadless Pacemakers

Overview

Prospective, non-randomized, multi-center study designed to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers

Full Title of Study: “Quantifying Patient Preferences for Leadless Pacemaker Devices”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 13, 2023

Detailed Description

The purpose of this study is to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers. The preference study is designed to elicit patient preferences for risks and features that vary between a dual chamber leadless pacemaker system and a dual chamber transvenous pacemaker system, to quantify their relative importance.

Interventions

  • Other: Patient Preference Survey
    • Patient preference survey on implantable cardiac pacemaker systems

Clinical Trial Outcome Measures

Primary Measures

  • Patient Preference for Pacemaker Device Features Survey
    • Time Frame: 1 year
    • Quantification of patient preference for pacemaker device features and characterization of heterogeneity in patient preferences

Participating in This Clinical Trial

Inclusion Criteria

  • Able to read and speak English to consent to participate in the survey – Willing and able to use a tablet or computer to complete the survey – Scheduled to undergo evaluation for a de novo cardiac pacemaker at the study site (patient may or may not have a known indication for a pacemaker at the time) Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Abbott Medical Devices
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shelby Reed, PhD, Principal Investigator, Duke Clinical Research Institute

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