N/A
N=117
Patient Preferences for Leadless Pacemakers
Cardiac Rhythm Disorder · Bradycardia · Cardiac Pacemaker Artificial
Bottom Line
View on ClinicalTrials.gov: NCT05327101 ↗Enrolled (actual)
117
Serious AEs
—
Results posted
Feb 2025
Primary outcome: Primary: Mean Rankings for Pacemaker Device Features — 2.3; 2.6; 2.2; 4.7 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Patient Preference Survey (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Rankings for Pacemaker Device Features |
2.3; 2.6; 2.2; 4.7; 5.1; 4.1 | — |
| PRIMARY Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters) |
0.340; -0.310; -0.030; 0.454; 0.253; -0.235 | — |
| PRIMARY Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations |
0.490; 1.411; 0.921; 0.562; 0.420; 0.242 | — |
| PRIMARY Maximum-acceptable Risks of a Complication |
13.4; 0; 0; 7.6; 0; 14.5 | — |
| PRIMARY Maximum-acceptable Risks of an Infection |
16.8; 0; 0; 8.9; 0; 17.8 | — |
| PRIMARY Probability of Choosing Specified Pacemakers - All 3 Profiles |
41.7; 8.0; 27.4; 4.5; 30.9; 87.5 | — |
| PRIMARY Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removable |
60.4; 64.0; 39.6; 36 | — |
| PRIMARY Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With Leads |
57.4; 8.4; 42.6; 91.6 | — |
| PRIMARY Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With Leads |
46.9; 4.9; 53.1; 95.1 | — |
| SECONDARY Constrained 2-class Latent-class Model Preference Weights |
50.5; 49.6 | — |
| SECONDARY Number of Discrete Choice Experiment Questions Answered |
41; 76 | — |
| SECONDARY Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class |
1.15; 0.99; 1.05; 1.55; 2.73; 0.98 | — |
Summary
Prospective, non-randomized, multi-center study designed to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05327101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.