Patient Preferences for Leadless Pacemakers

NCT05327101 | Completed Results

• 1 other identifier: ABT-CIP-10435
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 11

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

Conditions

Cardiac Rhythm Disorder; Bradycardia; Cardiac Pacemaker Artificial

Outcome Measures

Primary Outcomes (9)

• Mean Rankings for Pacemaker Device Features

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

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

Secondary Outcomes (3)

• Constrained 2-class Latent-class Model Preference Weights

  Baseline

• Number of Discrete Choice Experiment Questions Answered

  Baseline

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

  Baseline

Interventions

Patient Preference Survey OTHER

Patient preference survey on implantable cardiac pacemaker systems

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

300 patients

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (11)

Honor Health

Scottsdale, Arizona, 85258, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Pacific Heart Institute

Santa Monica, California, 90404, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Prairie Education & Research Cooperative

Springfield, Illinois, 62769, United States

Location

Charlton Memorial Hospital

Fall River, Massachusetts, 02720, United States

Location

New York Presbyterian Hospital/Cornell University

New York, New York, 10021, United States

Location

Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• Reed SD, Yang JC, Wallace MJ, Sutphin J, Johnson FR, Ozdemir S, Delgado SM, Goates S, Harbert N, Lo M, Rajagopalan B, Ip JE, Al-Khatib SM. Patient Preferences for Features Associated With Leadless Versus Conventional Transvenous Cardiac Pacemakers. Circ Cardiovasc Qual Outcomes. 2024 Dec;17(12):e011168. doi: 10.1161/CIRCOUTCOMES.124.011168. Epub 2024 Nov 21.

  PMID: 39569505 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Bradycardia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephanie Delgado
• Organization: Abbott Medical Devices

stephanie.delgado1@abbott.com

818-493-3285

Study Officials

• Shelby Reed, PhD

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 14, 2022
• Study Start: March 28, 2022
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: February 20, 2025
• Results First Posted: February 20, 2025

Record last verified: 2025-01

Locations

US (11)