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NCT Number: NCT04831125

Conduction System Pacing International Registry (CONSPIRE)

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.

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Key information

Conditions

Bradyarrhythmia Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center, Maastricht, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Age < 18 years
  • Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
  • Pregnancy
  • Difficulty with follow-up

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. QRS duration measured by electrocardiography after implant

    Time frame: Month 0, pre discharge

    Data will be collected on QRS duration (milliseconds) after implant procedure

  5. 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

  6. Procedure-related complications

    Time frame: Through 12 months

    Data will be collected to characterize procedure-related complications

  7. Changes in left ventricular ejection fraction

    Time frame: Through 12 months

    Data will be collected to characterize changes in left ventricular ejection fraction

  8. Changes in chamber dimension

    Time frame: Through 12 months

    Data will be collected to characterize changes in chamber dimension

  9. 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

  10. 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

  11. Sustained ventricular arrhythmia occurrences

    Time frame: Through 12 months

    Data will be collected to characterize sustained ventricular arrhythmia occurrences

  12. System-related complications

    Time frame: Through 12 months

    Data will be collected to characterize system-related complications

  13. Lead-related complications

    Time frame: Through 12 months

    Data will be collected to characterize lead-related complications

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Biotronik SE & Co. KG

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 5, 2021
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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