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Completed

NCT Number: NCT05327101

Patient Preferences for Leadless Pacemakers

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Honor Health, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Preference Survey

Other

Patient preference survey on implantable cardiac pacemaker systems

Primary outcomes

  1. Mean Rankings for Pacemaker Device Features

    Time frame: Baseline

    Ranking of six pacemaker device features from most concerning (1) to least concerning (6)

  2. Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)

    Time frame: Baseline

    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.

  3. Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations

    Time frame: Baseline

    The standard deviations representing the degree of variation in preference weights, with larger estimates representing preference heterogeneity.

  4. Maximum-acceptable Risks of a Complication

    Time frame: Baseline

    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.

  5. Maximum-acceptable Risks of an Infection

    Time frame: Baseline

    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.

  6. Probability of Choosing Specified Pacemakers - All 3 Profiles

    Time frame: Baseline

    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.

  7. Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removable

    Time frame: Baseline

    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.

  8. Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With Leads

    Time frame: Baseline

    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.

  9. Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With Leads

    Time frame: Baseline

    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.

Secondary outcomes

  1. Constrained 2-class Latent-class Model Preference Weights

    Time frame: Baseline

    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.

  2. Number of Discrete Choice Experiment Questions Answered

    Time frame: Baseline

    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.

  3. Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Quantifying Patient Preferences for Leadless Pacemaker Devices

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2022
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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