Patient Preferences for Leadless Pacemakers

NCT ID: NCT05327101

Last Updated: 2025-02-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-28

Study Completion Date

2023-06-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Rhythm Disorder Bradycardia Cardiac Pacemaker Artificial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Patient Preference Survey

Patient preference survey on implantable cardiac pacemaker systems

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shelby Reed, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Honor Health

Scottsdale, Arizona, United States

Site Status

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Site Status

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Site Status

Pacific Heart Institute

Santa Monica, California, United States

Site Status

Baptist Medical Center

Jacksonville, Florida, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Prairie Education & Research Cooperative

Springfield, Illinois, United States

Site Status

Charlton Memorial Hospital

Fall River, Massachusetts, United States

Site Status

New York Presbyterian Hospital/Cornell University

New York, New York, United States

Site Status

Hightower Clinical

Oklahoma City, Oklahoma, United States

Site Status

University of Utah Hospital

Salt Lake City, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39569505 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ABT-CIP-10435

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Clinical Study of LBBP
NCT04919447 UNKNOWN