Patient Preferences for Leadless Pacemakers
- Conditions
- BradycardiaCardiac Rhythm DisorderCardiac Pacemaker Artificial
- Registration Number
- NCT05327101
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
Prospective, non-randomized, multi-center study designed to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
- 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)
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Rankings for Pacemaker Device Features Baseline Ranking of six pacemaker device features from most concerning (1) to least concerning (6)
Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) 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.
Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations Baseline The standard deviations representing the degree of variation in preference weights, with larger estimates representing preference heterogeneity.
Maximum-acceptable Risks of a Complication 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.
Maximum-acceptable Risks of an Infection 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.
Probability of Choosing Specified Pacemakers - All 3 Profiles 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.
Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removable 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.
Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With Leads 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.
Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With Leads 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 Outcome Measures
Name Time Method Constrained 2-class Latent-class Model Preference Weights 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.
Number of Discrete Choice Experiment Questions Answered 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.
Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class 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.
Trial Locations
- Locations (11)
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
Charlton Memorial Hospital
🇺🇸Fall River, Massachusetts, United States
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
Arrhythmia Research Group
🇺🇸Jonesboro, Arkansas, United States
Honor Health
🇺🇸Scottsdale, Arizona, United States
Pacific Heart Institute
🇺🇸Santa Monica, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Prairie Education & Research Cooperative
🇺🇸Springfield, Illinois, United States
New York Presbyterian Hospital/Cornell University
🇺🇸New York, New York, United States
Hightower Clinical
🇺🇸Oklahoma City, Oklahoma, United States