Clinical trial NCT05327101: Patient Preferences for Leadless Pacemakers
Official title: Quantifying Patient Preferences for Leadless Pacemaker Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Rhythm Disorder
Bradycardia
Cardiac Pacemaker Artificial
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 patients

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.

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

Primary outcomes:
measure: Mean Rankings for Pacemaker Device Features
timeFrame: Baseline
measure: Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)
timeFrame: Baseline
measure: Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations
timeFrame: Baseline
measure: Maximum-acceptable Risks of a Complication
timeFrame: Baseline
measure: Maximum-acceptable Risks of an Infection
timeFrame: Baseline
measure: Probability of Choosing Specified Pacemakers - All 3 Profiles
timeFrame: Baseline
measure: Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removable
timeFrame: Baseline
measure: Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With Leads
timeFrame: Baseline
measure: Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With Leads
timeFrame: Baseline
Secondary outcomes:
measure: Constrained 2-class Latent-class Model Preference Weights
timeFrame: Baseline
measure: Number of Discrete Choice Experiment Questions Answered
timeFrame: Baseline
measure: Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class
timeFrame: Baseline
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative
state: Illinois
city: Fall River
country: United States
facility: Charlton Memorial Hospital
state: Massachusetts
city: New York
country: United States
facility: New York Presbyterian Hospital/Cornell University
state: New York
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: Duke Clinical Research Institute
name: Shelby Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References: