Conduction System Pacing International Registry (CONSPIRE)

NCT04831125 | Completed

• 1 other identifier: IRB20-1601
• Study Type: observational
• Target: 383
• Locations: 4 countries
• Sites: 8

Brief 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. 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.

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)

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (1)

Individuals receiving conduction system pacing

Other: Data collection

Interventions

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.

Individuals receiving conduction system pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead
• Biotronik SE & Co. KG: collaborator

Study Sites (8)

University of Arizona

Tucson, Arizona, 85719, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Icahn School of Medicine at Mount Sinai & Mount Sinai Hospital

New York, New York, 10029, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Health Research Institute Hospital La Fe

Valencia, Spain

Location

Lund University

Lund, Sweden

Location

MeSH Terms

Conditions

Bradycardia; Heart Failure

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gaurav A Upadhyay, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: April 5, 2021
• Study Start: April 4, 2021
• Primary Completion: February 5, 2026
• Study Completion: February 5, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); US (5); SE (1); ES (1)