Cardiac Rhythm DisorderNCT05327101

Patient Preferences for Leadless Pacemakers

An observational study of Cardiac Rhythm Disorder and Bradycardia, run by Abbott Medical Devices at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Rhythm Disorder, Bradycardia, Cardiac Pacemaker Artificial
What is being tested?: Patient Preference Survey
How many people: 117 participants
Where: 11 sitesUnited States
Study dates: 28 Mar 2022to 13 Jun 2023
How long will I take part?: 1 Day
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

Study population: 300 patients

Who may be able to join

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)

Who cannot join

None

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Rush University Medical Center
Chicago, Illinois, 60612
Charlton Memorial Hospital
Fall River, Massachusetts, 02720
Baptist Medical Center
Jacksonville, Florida, 32207
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
New York Presbyterian Hospital/Cornell University
New York, New York, 10021
Hightower Clinical
Oklahoma City, Oklahoma, 73102
University of Utah Hospital
Salt Lake City, Utah, 84132
Pacific Heart Institute
Santa Monica, California, 90404
Honor Health
Scottsdale, Arizona, 85258
Prairie Education & Research Cooperative
Springfield, Illinois, 62769

Other trials in United States

About this study

Official title: Quantifying Patient Preferences for Leadless Pacemaker Devices

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

Read the 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.

Conditions: Cardiac Rhythm Disorder, Bradycardia, Cardiac Pacemaker Artificial
Being tested: Patient Preference Survey
Medical subject headings: Arrhythmias, Cardiac, Bradycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patient Preference SurveyOther
Patient preference survey on implantable cardiac pacemaker systems

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Rankings for Pacemaker Device Features
Ranking of six pacemaker device features from most concerning (1) to least concerning (6)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline

Secondary outcomes (3)

Constrained 2-class Latent-class Model Preference Weights
Latent-class (LC) analysis was used to identify systematically different preference patterns across respondents. LC analysis provides a unique set of estimates of preference weights for a prespecified number of preference classes. Respondents are probabilistically assigned to classes based on the similarity of their responses to the overall preference pattern identified in each class.
Measured: Baseline
Number of Discrete Choice Experiment Questions Answered
Number of Discrete choice experiment (DCE) questions answered by 117 respondents who answered at least the first 8 DCE questions. After respondents answered 8 DCE questions, they were asked if they would like to complete 4 additional questions.
Measured: Baseline
Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class
Respondent characteristics can be associated with class membership probabilities to "profile" the classes. These results show if respondents with certain characteristics are more likely to be in one class versus the other. The odds ratios of being in the transvenous class versus the leadless class for patient characteristics. Odds ratios greater than 1 indicate a higher likelihood of being in the class preferring transvenous pacemakers and pacemakers with longer time since government approval.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 202213 Jun 2023

First posted14 Apr 2022
Study start28 Mar 2022
Primary completion13 Jun 2023
Study completion13 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cardiac Rhythm DisorderStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 117 participants (actual)
Target duration: 1 Day

IDs, dates and publications

ClinicalTrials.gov ID: NCT05327101
Sponsor's protocol ID: ABT-CIP-10435
Status last verified: Jan 2025
First submitted: 4 Apr 2022
Last updated: 20 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 39569505

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quantifying Patient Preferences for Leadless Pacemaker Devices
ClinicalTrials.gov ID: NCT05327101
Acronym / sponsor ID: ABT-CIP-10435
Conditions: Cardiac Rhythm Disorder, Bradycardia, Cardiac Pacemaker Artificial
Study type: Observational
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 28 Mar 2022 (actual)
Primary completion: 13 Jun 2023 (actual)
Study completion: 13 Jun 2023 (actual)
First posted: 14 Apr 2022 (actual)
Results: Posted 20 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Day

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: 300 patients

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patient Preference SurveyPatient preference survey on implantable cardiac pacemaker systems	Other	–

Primary outcome

Mean Rankings for Pacemaker Device Features
Time frame: Baseline
Ranking of six pacemaker device features from most concerning (1) to least concerning (6)
Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)
Time frame: Baseline
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.
Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations
Time frame: Baseline
The standard deviations representing the degree of variation in preference weights, with larger estimates representing preference heterogeneity.
Maximum-acceptable Risks of a Complication
Time frame: Baseline
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.
Maximum-acceptable Risks of an Infection
Time frame: Baseline
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.
Probability of Choosing Specified Pacemakers - All 3 Profiles
Time frame: Baseline
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.
Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Leadless Pacemaker Non-removable
Time frame: Baseline
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.
Probability of Choosing Specified Pacemakers - Leadless Pacemaker Removable vs. Pacemaker With Leads
Time frame: Baseline
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.
Probability of Choosing Specified Pacemakers - Leadless Pacemaker Non-removable vs. Pacemaker With Leads
Time frame: Baseline
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.

3 secondary outcomes

Constrained 2-class Latent-class Model Preference Weights
Time frame: Baseline
Number of Discrete Choice Experiment Questions Answered
Time frame: Baseline
Association of Patient Characteristics With Membership in the Transvenous Class Versus the Leadless Class
Time frame: Baseline

Results and safety

Results posted to the registry on 20 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patient Preferences Survey	117	117

Primary outcome: Mean Rankings for Pacemaker Device Features

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Patient Preferences Survey n = 90
Insertion procedure	2.3 (1.3)
Pacemaker type	2.6 (1.2)
Pacemaker location	2.2 (1.0)
No heavy lifting for 6 weeks	4.7 (1.5)
Scar on chest	5.1 (1.0)
Lump on chest	4.1 (1.4)

Population analysed: Each respondent was asked to rank the six features (insertion procedure, pacemaker type, pacemaker location, no heavy lifting, scar on chest, and lump on chest) from most concerning (1) to least concerning (6). The table reports the mean ranking for each device feature evaluated on a scale from 1-6. The number of respondents is 90 because 27 respondents skipped the ranking questions

Primary outcome: Results From RPL Model of Discrete Choice Experiment Choice Questions - Preference Weights (Effect-coded Parameters)

Time frame: Baseline. Number. Unit: preference weights

Measure	Patient Preferences Survey n = 117
Pacemaker type - Leadless, removable	0.340
Pacemaker type - Leadless, non-removable	-0.310
Pacemaker type - Transvenous	-0.030
Battery life - 15 years	0.454
Battery life - 12 years	0.253
Battery life - 8 years	-0.235
Battery life - 5 years	-0.473
Time since regulatory approval - 10 years	0.212

Primary outcome: Results From RPL Model of Discrete Choice Experiment Choice Questions- Standard Deviations

Time frame: Baseline. Number. Unit: standard deviation

Measure	Patient Preferences Survey n = 117
Pacemaker type - Leadless, removable	0.490
Pacemaker type - Leadless, non-removable	1.411
Pacemaker type - Transvenous	0.921
Battery life - 15 years	0.562
Battery life - 12 years	0.420
Battery life - 8 years	0.242
Battery life - 5 years	0.741
Time since regulatory approval - 10 years	0.345

Primary outcome: Maximum-acceptable Risks of a Complication

Time frame: Baseline. Number (95% Confidence Interval). Unit: percentage of maximum-acceptable risk

Measure	Patient Preferences Survey n = 117
Patients in leadless class willing to accept MAR for removable leadless rather than transvenous	13.4 (6.4 to 23.8)
Patients in transvenous class willing to accept MAR for removable leadless rather than transvenous	0 (0 to 0)
Patients in leadless class willing to accept MAR for transvenous rather than removable leadless	0 (0 to 0)
Patients in transvenous class willing to accept MAR for transvenous rather than removable leadless	7.6 (1.7 to 16.8)
Patients in leadless class willing to accept MAR for transvenous rather than nonremovable leadless	0 (0 to 0)
Patients in transvenous class willing to accept MAR for transvenous instead of nonremovable leadless	14.5 (7.3 to 36.6)
Patients in leadless class willing to accept MAR for removable rather than nonremovable leadless	5.1 (0.4 to 9.2)
Patients in transvenous class willing to accept MAR for removable rather than nonremovable leadless	6.3 (2.4 to 10.5)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious and other [non-serious] adverse events were not collected or assessed as part of the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patient Preferences Survey	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39569505Reed 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shelby Reed, PhD principal investigator

Duke Clinical Research Institute

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Rhythm Disorder and Bradycardia, run by Abbott Medical Devices at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Rankings for Pacemaker Device Features (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05327101, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.