BradyarrhythmiaNCT04831125
Conduction System Pacing International Registry (CONSPIRE)
An observational study of Bradyarrhythmia and Heart Failure, run by University of Chicago at 8 sites in 4 countries.
Trial summary
The purpose of this registry study is to collect information about routine clinical practices with device implantation to treat bradycardia and cardiac systolic dysfunction (heart rhythm disorders) across global centers of excellence in cardiac pacing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradyarrhythmia, Heart Failure
- What is being tested?
- Data collection
- How many people
- 383 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 4 Apr 2021to 5 Feb 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Individuals receiving conduction system pacing * Any presence of symptomatic bradyarrhythmia requiring pacing therapy * Any presence of heart failure (HF) with evidence of wide QRS or anticipated requirement for >40% ventricular pacing
Who may be able to join
- Meets American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines for bradycardia, or
- Meets ACC/AHA/HRS guidelines for cardiac resynchronization therapy (CRT).
Who cannot join
- Age < 18 years
- Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
- Pregnancy
- Difficulty with follow-up
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States5 sites
University of Chicago
Chicago, Illinois, 60637
Icahn School of Medicine at Mount Sinai & Mount Sinai Hospital
New York, New York, 10029
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Arizona
Tucson, Arizona, 85719
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
About this study
The purpose of this registry study is to collect information about routine clinical practices with device implantation to treat bradycardia and cardiac systolic dysfunction (heart rhythm disorders) across global centers of excellence in cardiac pacing. In particular, this study will examine the use of conduction system pacing (CSP) in clinical practice. Information collected in the registry will help researchers better characterize strengths and limitations of current technology and treatments.
Read the detailed description
During this past decade, there has been a dramatic surge in interest in new physiologic pacing strategies which engage and take advantage of the intrinsic cardiac conduction system. These approaches include His bundle pacing (HBP) as well as approaches which seek to pace the proximal left conduction system (LCS), including left bundle branch area pacing (LBBAP) or pacing in the region of the left posterior fascicle. Left ventricular septal pacing (LVS) has also been proposed as another means to avoid dyssynchrony with early data suggestive of comparable electrical synchronization as biventricular pacing. These approaches utilize approved pacing systems and leads which are delivered to new targets in the His-Purkinje system or LV endocardial fibers. Despite the growing interest in HBP, LCS, and LVS, the majority of data are from disparate cohort studies and there has been a lack of uniformity in assembling data or analyzing and interpreting outcomes.
The goal of the Conduction System Pacing International Registry (CONSPIRE) is to systematically and prospectively collect data across multiple centers of excellence on the early implementation of permanent conduction system pacing devices in order to characterize strengths and limitations of current technology. The study will evaluate patient selection, intraprocedural characteristics, and clinical outcomes among patients receiving conduction system pacing (CSP) as part of their routine clinical care.
- Conditions
- Bradyarrhythmia, Heart Failure
- Being tested
- Data collection
- Keywords
- Conduction system pacing (CSP), His bundle pacing (HBP), Left ventricular septal pacing (LVS), Left bundle branch area pacing (LBBAP), Proximal left conduction system pacing (LCS)
- Medical subject headings
- Bradycardia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection on the use of pacemaker, implantable cardioverter-defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices and leads that are approved for clinical use.
| Study group | Role | What they receive |
|---|---|---|
| Individuals receiving conduction system pacing | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant characteristics
Data will be collected on CSP lead position based on reported anatomical position (e.g., His bundle location, left bundle branch area or left bundle branch pacing location, or left ventricular septal pacing location)
Measured: Month 0, during procedure
QRS duration measured by electrocardiography at baseline
Data will be collected on QRS duration (milliseconds) prior to implant
Measured: Baseline, within 1 month prior to procedure
QRS morphology captured by surface electrocardiography at baseline
Data will be collected on QRS morphology (e.g., narrow QRS, left bundle branch block, right bundle branch block, left anterior or posterior hemiblock, nonspecific intraventricular conduction delay, or predominantly paced QRS) prior to implant
Measured: Baseline, within 1 month prior to procedure
QRS duration measured by electrocardiography after implant
Data will be collected on QRS duration (milliseconds) after implant procedure
Measured: Month 0, pre discharge
QRS morphology captured by surface electrocardiography after implant
Data will be collected on QRS morphology [e.g., narrow QRS, left bundaloid QRS in V1, or right bundaloid QRS in V1] after implant procedure
Measured: Month 0, pre discharge
Procedure-related complications
Data will be collected to characterize procedure-related complications
Measured: Through 12 months
Changes in left ventricular ejection fraction
Data will be collected to characterize changes in left ventricular ejection fraction
Measured: Through 12 months
Changes in chamber dimension
Data will be collected to characterize changes in chamber dimension
Measured: Through 12 months
Heart failure hospitalizations
Data will be collected to characterize heart failure hospitalizations within the first 12 months after device implant
Measured: Through 12 months
Any-cause mortalities
Data will be collected to characterize any-cause mortalities within the first 12 months after device implant
Measured: Through 12 months
Sustained ventricular arrhythmia occurrences
Data will be collected to characterize sustained ventricular arrhythmia occurrences
Measured: Through 12 months
System-related complications
Data will be collected to characterize system-related complications
Measured: Through 12 months
Lead-related complications
Data will be collected to characterize lead-related complications
Measured: Through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start4 Apr 2021
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradyarrhythmiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 383 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Sponsor
- Investigators
- Gaurav A Upadhyay, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831125
- Sponsor's protocol ID
- IRB20-1601
- Status last verified
- Feb 2026
- First submitted
- 15 Mar 2021
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conduction System Pacing International Registry (CONSPIRE)
- ClinicalTrials.gov ID
- NCT04831125
- Acronym / sponsor ID
- IRB20-1601
- Conditions
- Bradyarrhythmia, Heart Failure
- Keywords
- Conduction system pacing (CSP), His bundle pacing (HBP), Left ventricular septal pacing (LVS), Left bundle branch area pacing (LBBAP), Proximal left conduction system pacing (LCS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Study start
- 4 Apr 2021 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this registry study is to collect information about routine clinical practices with device implantation to treat bradycardia and cardiac systolic dysfunction (heart rhythm disorders) across global centers of excellence in cardiac pacing. In particular, this study will examine the use of conduction system pacing (CSP) in clinical practice. Information collected in the registry will help researchers better characterize strengths and limitations of current technology and treatments.
Detailed description
During this past decade, there has been a dramatic surge in interest in new physiologic pacing strategies which engage and take advantage of the intrinsic cardiac conduction system. These approaches include His bundle pacing (HBP) as well as approaches which seek to pace the proximal left conduction system (LCS), including left bundle branch area pacing (LBBAP) or pacing in the region of the left posterior fascicle. Left ventricular septal pacing (LVS) has also been proposed as another means to avoid dyssynchrony with early data suggestive of comparable electrical synchronization as biventricular pacing. These approaches utilize approved pacing systems and leads which are delivered to new targets in the His-Purkinje system or LV endocardial fibers. Despite the growing interest in HBP, LCS, and LVS, the majority of data are from disparate cohort studies and there has been a lack of uniformity in assembling data or analyzing and interpreting outcomes.
The goal of the Conduction System Pacing International Registry (CONSPIRE) is to systematically and prospectively collect data across multiple centers of excellence on the early implementation of permanent conduction system pacing devices in order to characterize strengths and limitations of current technology. The study will evaluate patient selection, intraprocedural characteristics, and clinical outcomes among patients receiving conduction system pacing (CSP) as part of their routine clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals receiving conduction system pacing | – | Other: Data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals receiving conduction system pacing * Any presence of symptomatic bradyarrhythmia requiring pacing therapy * Any presence of heart failure (HF) with evidence of wide QRS or anticipated requirement for >40% ventricular pacing
Key inclusion criteria (2 listed)
- Meets American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines for bradycardia, or
- Meets ACC/AHA/HRS guidelines for cardiac resynchronization therapy (CRT).
Key exclusion criteria (4 listed)
- Age < 18 years
- Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
- Pregnancy
- Difficulty with follow-up
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 |
|---|---|---|
| Data collectionData collection on the use of pacemaker, implantable cardioverter-defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices and leads that are approved for clinical use. | Other | Individuals receiving conduction system pacing |
Primary outcome
Implant characteristics
Time frame: Month 0, during procedure
Data will be collected on CSP lead position based on reported anatomical position (e.g., His bundle location, left bundle branch area or left bundle branch pacing location, or left ventricular septal pacing location)
QRS duration measured by electrocardiography at baseline
Time frame: Baseline, within 1 month prior to procedure
Data will be collected on QRS duration (milliseconds) prior to implant
QRS morphology captured by surface electrocardiography at baseline
Time frame: Baseline, within 1 month prior to procedure
Data will be collected on QRS morphology (e.g., narrow QRS, left bundle branch block, right bundle branch block, left anterior or posterior hemiblock, nonspecific intraventricular conduction delay, or predominantly paced QRS) prior to implant
QRS duration measured by electrocardiography after implant
Time frame: Month 0, pre discharge
Data will be collected on QRS duration (milliseconds) after implant procedure
QRS morphology captured by surface electrocardiography after implant
Time frame: Month 0, pre discharge
Data will be collected on QRS morphology [e.g., narrow QRS, left bundaloid QRS in V1, or right bundaloid QRS in V1] after implant procedure
Procedure-related complications
Time frame: Through 12 months
Data will be collected to characterize procedure-related complications
Changes in left ventricular ejection fraction
Time frame: Through 12 months
Data will be collected to characterize changes in left ventricular ejection fraction
Changes in chamber dimension
Time frame: Through 12 months
Data will be collected to characterize changes in chamber dimension
Heart failure hospitalizations
Time frame: Through 12 months
Data will be collected to characterize heart failure hospitalizations within the first 12 months after device implant
Any-cause mortalities
Time frame: Through 12 months
Data will be collected to characterize any-cause mortalities within the first 12 months after device implant
Sustained ventricular arrhythmia occurrences
Time frame: Through 12 months
Data will be collected to characterize sustained ventricular arrhythmia occurrences
System-related complications
Time frame: Through 12 months
Data will be collected to characterize system-related complications
Lead-related complications
Time frame: Through 12 months
Data will be collected to characterize lead-related complications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Gaurav A Upadhyay, MD principal investigator
University of Chicago
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradyarrhythmia and Heart Failure, run by University of Chicago at 8 sites in 4 countries.
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 2 inclusion and 4 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 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Netherlands, Spain, Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Implant characteristics (time frame: Month 0, during procedure). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2026.