Patient Preferences for Leadless Pacemakers

October 23, 2023 updated by: Abbott Medical Devices

Quantifying Patient Preferences for Leadless Pacemaker Devices

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Honor Health
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Arrhythmia Research Group
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital
    • California
      • Santa Monica, California, United States, 90404
        • Pacific Heart Institute
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Springfield, Illinois, United States, 62769
        • Prairie Education & Research Cooperative
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Charlton Memorial Hospital
    • New York
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital/Cornell University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Hightower Clinical
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

300 patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Shelby Reed, PhD, Duke Clinical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Actual)

June 13, 2023

Study Completion (Actual)

June 13, 2023

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10435

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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