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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Bradyarrhythmia
• Intervention / Treatment: Other: Data collection

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 Type: Observational
• Enrollment (Actual): 383

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht University Medical Center
• Spain
  • Valencia, Spain
    • Health Research Institute Hospital La Fe
• Sweden
  • Lund, Sweden
    • Lund University
• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • University of Arizona
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai & Mount Sinai Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Wyoming Valley Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals receiving conduction system pacing	Other: Data collection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Month 0, during procedure
QRS duration measured by electrocardiography at baseline	Data will be collected on QRS duration (milliseconds) prior to implant	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	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	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	Month 0, pre discharge
Procedure-related complications	Data will be collected to characterize procedure-related complications	Through 12 months
Changes in left ventricular ejection fraction	Data will be collected to characterize changes in left ventricular ejection fraction	Through 12 months
Changes in chamber dimension	Data will be collected to characterize changes in chamber dimension	Through 12 months
Heart failure hospitalizations	Data will be collected to characterize heart failure hospitalizations within the first 12 months after device implant	Through 12 months
Any-cause mortalities	Data will be collected to characterize any-cause mortalities within the first 12 months after device implant	Through 12 months
Sustained ventricular arrhythmia occurrences	Data will be collected to characterize sustained ventricular arrhythmia occurrences	Through 12 months
System-related complications	Data will be collected to characterize system-related complications	Through 12 months
Lead-related complications	Data will be collected to characterize lead-related complications	Through 12 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Gaurav A Upadhyay, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2021
• Primary Completion (Actual): February 5, 2026
• Study Completion (Actual): February 5, 2026

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• 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)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Heart Failure; Bradycardia; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: IRB20-1601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No