Patient Preferences for Leadless Pacemakers

Bradycardia Clinical Trial

Official title:

Quantifying Patient Preferences for Leadless Pacemaker Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05327101
• Other study ID #: ABT-CIP-10435
• Status: Completed
• Start date: March 28, 2022
• Est. completion date: June 13, 2023

Study information

• Verified date: October 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Prospective, non-randomized, multi-center study designed to quantify patient preferences pertaining to risks and features of conventional transvenous pacemakers and leadless pacemakers

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Bradycardia
• Cardiac Rhythm Disorder

Intervention

Other:
• Patient Preference Survey
Patient preference survey on implantable cardiac pacemaker systems

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Charlton Memorial Hospital	Fall River	Massachusetts
United States	Baptist Medical Center	Jacksonville	Florida
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	New York Presbyterian Hospital/Cornell University	New York	New York
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	University of Utah Hospital	Salt Lake City	Utah
United States	Pacific Heart Institute	Santa Monica	California
United States	Honor Health	Scottsdale	Arizona
United States	Prairie Education & Research Cooperative	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Preference for Pacemaker Device Features Survey	Quantification of patient preference for pacemaker device features and characterization of heterogeneity in patient preferences	1 year