Skip to content

Patient Preferences for Leadless Pacemakers

Quantifying Patient Preferences for Leadless Pacemaker Devices

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05327101
Enrollment
117
Registered
2022-04-14
Start date
2022-03-28
Completion date
2023-06-13
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia, Cardiac Pacemaker Artificial, Cardiac Rhythm Disorder

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.

Interventions

OTHERPatient Preference Survey

Patient preference survey on implantable cardiac pacemaker systems

Sponsors

Abbott Medical Devices
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With LeadsBaselinePreference 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.
Probability of Choosing Specified Pacemakers - All 3 ProfilesBaselinePreference 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-removableBaselinePreference 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 LeadsBaselinePreference 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.
Mean Rankings for Pacemaker Device FeaturesBaselineRanking 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)BaselineThe 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.
Maximum-acceptable Risks of a ComplicationBaselineMaximum-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.
Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsBaselineThe standard deviations representing the degree of variation in preference weights, with larger estimates representing preference heterogeneity.
Maximum-acceptable Risks of an InfectionBaselineMaximum-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.

Secondary

MeasureTime frameDescription
Number of Discrete Choice Experiment Questions AnsweredBaselineNumber 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 ClassBaselineRespondent 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.
Constrained 2-class Latent-class Model Preference WeightsBaselineLatent-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.

Countries

United States

Participant flow

Recruitment details

Patients were recruited from Aveir™ DR IDE trial study sites. One-hundred seventeen patients were recruited and completed the survey instrument.

Participants by arm

ArmCount
Patient Preferences Survey
Patients were recruited from Aveir™ DR IDE trial study sites. To minimize selection bias, patients meeting specified criteria and agreeing to participate were asked to complete the patient-preference survey before being approached about their potential interest in enrolling in the IDE trial. Thus, they completed the patient-preference survey before they received information about dual-chamber pacemakers from the site physician and/or the Aveir™ DR IDE study and before they received a pacemaker if they ultimately received one.
117
Total117

Baseline characteristics

CharacteristicPatient Preferences Survey
Age, Customized67.3 years
STANDARD_DEVIATION 14.6
BMI28.1 kg/m^2
STANDARD_DEVIATION 5.6
Employment
Disabled
11 Participants
Employment
Employed with hourly pay
13 Participants
Employment
Employed with salary
18 Participants
Employment
Homemaker
4 Participants
Employment
Not working and NOT looking for a job
1 Participants
Employment
Not working but looking for a job
1 Participants
Employment
Other
0 Participants
Employment
Retired
68 Participants
Employment
Self-employed
9 Participants
Employment
Student
1 Participants
Employment
Unable to work or on disability
1 Participants
Employment
Volunteer work
3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
113 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
Health Insurance
I do not have health insurance
2 participants
Health Insurance
Medicaid
7 participants
Health Insurance
Medicare alone
27 participants
Health Insurance
Medicare and supplemental insurance
53 participants
Health Insurance
Other
1 participants
Health Insurance
Through a state or federal insurance exchange
11 participants
Health Insurance
Through my (or another person's) employer or union
26 participants
Health Insurance
Veterans affairs
6 participants
Height67.8 inches
STANDARD_DEVIATION 4.5
Highest Level of Education
4-year college degree (such as BA, BS)
26 Participants
Highest Level of Education
Associate's degree or 2-year college degree
16 Participants
Highest Level of Education
Graduate or professional degree (such as MBA, MS, MA, MD, PhD)
15 Participants
Highest Level of Education
High school or equivalent (such as GED)
19 Participants
Highest Level of Education
Less than high school
4 Participants
Highest Level of Education
Missing
2 Participants
Highest Level of Education
Some college but no degree
22 Participants
Highest Level of Education
Some graduate school but no degree
3 Participants
Highest Level of Education
Some high school
3 Participants
Highest Level of Education
Technical school
7 Participants
Marital Status
Divorced or separated
19 Participants
Marital Status
Married/living as married
81 Participants
Marital Status
Other
1 Participants
Marital Status
Single/never married
7 Participants
Marital Status
Widowed/surviving partner
9 Participants
Race
American Indian or Alaska Native
1 Participants
Race
Asian
3 Participants
Race
Black or African American
4 Participants
Race
Native Hawaiian or Other Pacific Islander
0 Participants
Race
Other
1 Participants
Race
White
110 Participants
Sex: Female, Male
Female
49 Participants
Sex: Female, Male
Male
68 Participants
Weight184.9 pounds
STANDARD_DEVIATION 43.5

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

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.

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Patient Preferences SurveyMaximum-acceptable Risks of a ComplicationPatients in leadless class willing to accept MAR for removable leadless rather than transvenous13.4 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of a ComplicationPatients in transvenous class willing to accept MAR for removable leadless rather than transvenous0 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of a ComplicationPatients in leadless class willing to accept MAR for transvenous rather than removable leadless0 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of a ComplicationPatients in transvenous class willing to accept MAR for transvenous rather than removable leadless7.6 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of a ComplicationPatients in leadless class willing to accept MAR for transvenous rather than nonremovable leadless0 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of a ComplicationPatients in transvenous class willing to accept MAR for transvenous instead of nonremovable leadless14.5 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of a ComplicationPatients in leadless class willing to accept MAR for removable rather than nonremovable leadless5.1 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of a ComplicationPatients in transvenous class willing to accept MAR for removable rather than nonremovable leadless6.3 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of a ComplicationTransvenous class patients willing to accept MAR for 10 yrs since government approval rather than 20.7 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of a ComplicationLeadless class patients willing to accept MAR for 10 yrs since government approval rather than 26.8 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of a ComplicationLeadless & transvenous class patients willing to accept MAR for 15 yrs of battery life instead of 26.7 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of a ComplicationLeadless & transvenous class patients willing to accept MAR for no discomfort rather than discomfort2.0 percentage of maximum-acceptable risk
Primary

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.

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Patient Preferences SurveyMaximum-acceptable Risks of an InfectionPatients in leadless class willing to accept MAR for removable leadless rather than transvenous16.8 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of an InfectionPatients in transvenous class willing to accept MAR for removable leadless rather than transvenous0 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of an InfectionPatients in leadless class willing to accept MAR for transvenous rather than removable leadless0 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of an InfectionPatients in transvenous class willing to accept MAR for transvenous rather than removable leadless8.9 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of an InfectionPatients in leadless class willing to accept MAR for transvenous rather than nonremovable leadless0 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of an InfectionPatients in transvenous class willing to accept MAR for transvenous instead of nonremovable leadless17.8 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of an InfectionPatients in leadless class willing to accept MAR for removable rather than nonremovable leadless4.7 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of an InfectionPatients in transvenous class willing to accept MAR for removable rather than nonremovable leadless6.6 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of an InfectionTransvenous class patients willing to accept MAR for 10 yrs since government approval rather than 20.8 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of an InfectionLeadless class patients willing to accept MAR for 10 yrs since government approval rather than 27.6 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of an InfectionLeadless & transvenous class patients willing to accept MAR for 15 yrs of battery life instead of 27.5 percentage of maximum-acceptable risk
Patient Preferences SurveyMaximum-acceptable Risks of an InfectionLeadless & transvenous class patients willing to accept MAR for no discomfort rather than discomfort1.9 percentage of maximum-acceptable risk
Primary

Mean Rankings for Pacemaker Device Features

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

Time frame: Baseline

Population: Each respondent was asked to rank the six features (insertion procedure, pacemaker type, pacemaker location, no heavy lifting, scar on chest, and lump on chest) from most concerning (1) to least concerning (6). The table reports the mean ranking for each device feature evaluated on a scale from 1-6. The number of respondents is 90 because 27 respondents skipped the ranking questions

ArmMeasureGroupValue (MEAN)Dispersion
Patient Preferences SurveyMean Rankings for Pacemaker Device FeaturesInsertion procedure2.3 score on a scaleStandard Deviation 1.3
Patient Preferences SurveyMean Rankings for Pacemaker Device FeaturesPacemaker type2.6 score on a scaleStandard Deviation 1.2
Patient Preferences SurveyMean Rankings for Pacemaker Device FeaturesPacemaker location2.2 score on a scaleStandard Deviation 1
Patient Preferences SurveyMean Rankings for Pacemaker Device FeaturesNo heavy lifting for 6 weeks4.7 score on a scaleStandard Deviation 1.5
Patient Preferences SurveyMean Rankings for Pacemaker Device FeaturesScar on chest5.1 score on a scaleStandard Deviation 1
Patient Preferences SurveyMean Rankings for Pacemaker Device FeaturesLump on chest4.1 score on a scaleStandard Deviation 1.4
Primary

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.

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - All 3 ProfilesProbability leadless class to choose profile: leadless pacemaker removable41.7 percentage of probability
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - All 3 ProfilesProbability transvenous class to choose profile: leadless pacemaker removable8.0 percentage of probability
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - All 3 ProfilesProbability leadless class to choose profile: leadless pacemaker non-removable27.4 percentage of probability
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - All 3 ProfilesProbability transvenous class to choose profile: leadless pacemaker non-removable4.5 percentage of probability
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - All 3 ProfilesProbability leadless class to choose profile: pacemaker with leads30.9 percentage of probability
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - All 3 ProfilesProbability transvenous class to choose profile: pacemaker with leads87.5 percentage of probability
Primary

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.

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With LeadsProbability leadless class to choose profile: leadless pacemaker non-removable46.9 percentage of probability
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With LeadsProbability transvenous class to choose profile: leadless pacemaker non-removable4.9 percentage of probability
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With LeadsProbability leadless class to choose profile: pacemaker with leads53.1 percentage of probability
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With LeadsProbability transvenous class to choose profile: pacemaker with leads95.1 percentage of probability
Primary

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.

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removableProbability leadless class to choose profile: leadless pacemaker removable60.4 percentage of probability
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removableProbability transvenous class to choose profile: leadless pacemaker removable64.0 percentage of probability
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removableProbability leadless class to choose profile: leadless pacemaker non-removable39.6 percentage of probability
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removableProbability transvenous class to choose profile: leadless pacemaker non-removable36 percentage of probability
Primary

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.

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With LeadsProbability leadless class to choose profile: leadless pacemaker removable57.4 percentage of probability
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With LeadsProbability transvenous class to choose profile: leadless pacemaker removable8.4 percentage of probability
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With LeadsProbability leadless class to choose profile: pacemaker with leads42.6 percentage of probability
Patient Preferences SurveyProbability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With LeadsProbability transvenous class to choose profile: pacemaker with leads91.6 percentage of probability
Primary

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.

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Pacemaker type - Leadless, removable0.340 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Pacemaker type - Leadless, non-removable-0.310 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Pacemaker type - Transvenous-0.030 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Battery life - 15 years0.454 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Battery life - 12 years0.253 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Battery life - 8 years-0.235 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Battery life - 5 years-0.473 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Time since regulatory approval - 10 years0.212 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Time since regulatory approval - 2 years-0.212 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Discomfort for 6 months - No discomfort0.099 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Discomfort for 6 months - Discomfort-0.099 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Risk of Complication - 1%0.957 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Risk of Complication - 5%0.396 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Risk of Complication - 10%-0.390 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Risk of Complication - 20%-0.963 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Risk of infection - 1%0.961 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Risk of infection - 5%0.408 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Risk of infection - 10%-0.132 preference weights
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)Risk of infection - 20%-1.237 preference weights
Primary

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.

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsPacemaker type - Leadless, removable0.490 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsPacemaker type - Leadless, non-removable1.411 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsPacemaker type - Transvenous0.921 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsBattery life - 15 years0.562 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsBattery life - 12 years0.420 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsBattery life - 8 years0.242 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsBattery life - 5 years0.741 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsTime since regulatory approval - 10 years0.345 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsTime since regulatory approval - 2 years0.345 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsDiscomfort for 6 months - No discomfort0.121 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsDiscomfort for 6 months - Discomfort0.121 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsRisk of Complication - 1%0.606 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsRisk of Complication - 5%0.346 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsRisk of Complication - 10%0.838 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsRisk of Complication - 20%1.790 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsRisk of infection - 1%0.683 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsRisk of infection - 5%0.293 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsRisk of infection - 10%0.077 standard deviation
Patient Preferences SurveyResults From RPL Model of Discrete Choice Experiment Choice Questions- Standard DeviationsRisk of infection - 20%1.052 standard deviation
Secondary

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.

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Patient Preferences SurveyAssociation of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless ClassMale1.15 odds ratio
Patient Preferences SurveyAssociation of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless ClassAge, per 1-year increase0.99 odds ratio
Patient Preferences SurveyAssociation of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless ClassBMI, per unit increase1.05 odds ratio
Patient Preferences SurveyAssociation of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless ClassMajor surgery requiring hospitalization in the last 5 years1.55 odds ratio
Patient Preferences SurveyAssociation of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless ClassSedentary lifestyle with light activity2.73 odds ratio
Patient Preferences SurveyAssociation of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless ClassInteraction of lifestyle and BMI0.98 odds ratio
Secondary

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.

Time frame: Baseline

ArmMeasureGroupValue (NUMBER)
Patient Preferences SurveyConstrained 2-class Latent-class Model Preference WeightsLeadless Class50.5 percentage of participants
Patient Preferences SurveyConstrained 2-class Latent-class Model Preference WeightsTransvenous class49.6 percentage of participants
Secondary

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.

Time frame: Baseline

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Patient Preferences SurveyNumber of Discrete Choice Experiment Questions Answered8 questions41 Participants
Patient Preferences SurveyNumber of Discrete Choice Experiment Questions Answered12 questions76 Participants

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026