Patient Preferences for Leadless Pacemakers

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: Bradycardia; Cardiac Rhythm Disorder; Cardiac Pacemaker Artificial
• Intervention / Treatment: Other: Patient Preference Survey

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

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

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Rankings for Pacemaker Device Features	Ranking of six pacemaker device features from most concerning (1) to least concerning (6)	Baseline
Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)	The preference weights for the RPL model. Effect-coded parameters generate log-odds preference weights representing the relative strength of preference for each attribute level versus the mean effect across levels normalized at zero. A higher weight indicates a more preferred level while a lower weight indicates a less preferred level.	Baseline
Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations	The standard deviations representing the degree of variation in preference weights, with larger estimates representing preference heterogeneity.	Baseline
Maximum-acceptable Risks of a Complication	Maximum-acceptable risk (MAR) of a complication was calculated for patients based off latent-class analysis with two groups-leadless class and transvenous class (see secondary outcome Constrained 2-class Latent-class model preference weights). The MAR represents risk level patients would be willing to accept to obtain their preferred pacemaker type, no discomfort, a device with longer battery life, and a device with more time since regulatory approval.	Baseline
Maximum-acceptable Risks of an Infection	Maximum-acceptable risk (MAR) of an infection was calculated for patients based off latent-class analysis with two groups-leadless class and transvenous class (see secondary outcome Constrained 2-class Latent-class model preference weights). The MAR represent the risk that patients would be willing to accept to obtain their preferred pacemaker type, no discomfort, a device with longer battery life, and a device with more time since regulatory approval.	Baseline
Probability of Choosing Specified Pacemakers - All 3 Profiles	Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable, leadless pacemaker non-removable, or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another.	Baseline
Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removable	Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable or leadless pacemaker non-removable. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another.	Baseline
Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With Leads	Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker removable or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another.	Baseline
Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With Leads	Preference weight estimates were used to calculate the predicted probabilities that patients would choose a hypothetical pacemaker profile out of three different pacemaker types- leadless pacemaker non-removable or pacemaker with leads. Attributes for each pacemaker profile were defined using historical or published values. Preference weights from the latent class model were used to compute the probability that respondents within each class preference would choose a pacemaker profile over another.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constrained 2-class Latent-class Model Preference Weights	Latent-class (LC) analysis was used to identify systematically different preference patterns across respondents. LC analysis provides a unique set of estimates of preference weights for a prespecified number of preference classes. Respondents are probabilistically assigned to classes based on the similarity of their responses to the overall preference pattern identified in each class.	Baseline
Number of Discrete Choice Experiment Questions Answered	Number of Discrete choice experiment (DCE) questions answered by 117 respondents who answered at least the first 8 DCE questions. After respondents answered 8 DCE questions, they were asked if they would like to complete 4 additional questions.	Baseline
Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class	Respondent characteristics can be associated with class membership probabilities to "profile" the classes. These results show if respondents with certain characteristics are more likely to be in one class versus the other. The odds ratios of being in the transvenous class versus the leadless class for patient characteristics. Odds ratios greater than 1 indicate a higher likelihood of being in the class preferring transvenous pacemakers and pacemakers with longer time since government approval.	Baseline

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Shelby Reed, PhD, Duke Clinical Research Institute

Study record dates

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Bradycardia; Arrhythmias, Cardiac
• 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