Conduction System Pacing International Registry (CONSPIRE)

Active, not recruiting

• Conditions: Bradyarrhythmia; Heart Failure
• Interventions: Other: Data collection

• Registration Number: NCT04831125
• Lead Sponsor: University of Chicago

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.

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 Timeline

• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-31
• Study Start: 2021-04-04
• Study First Posted: 2021-04-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-18
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 383

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals receiving conduction system pacing	Data collection	-

Primary Outcome Measures

Name	Time	Method
QRS duration measured by electrocardiography after implant	Month 0, pre discharge	Data will be collected on QRS duration (milliseconds) after implant procedure
QRS morphology captured by surface electrocardiography after implant	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
Sustained ventricular arrhythmia occurrences	Through 12 months	Data will be collected to characterize sustained ventricular arrhythmia occurrences
Implant characteristics	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	Baseline, within 1 month prior to procedure	Data will be collected on QRS duration (milliseconds) prior to implant
Procedure-related complications	Through 12 months	Data will be collected to characterize procedure-related complications
Changes in chamber dimension	Through 12 months	Data will be collected to characterize changes in chamber dimension
Any-cause mortalities	Through 12 months	Data will be collected to characterize any-cause mortalities within the first 12 months after device implant
System-related complications	Through 12 months	Data will be collected to characterize system-related complications
QRS morphology captured by surface electrocardiography at baseline	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
Changes in left ventricular ejection fraction	Through 12 months	Data will be collected to characterize changes in left ventricular ejection fraction
Heart failure hospitalizations	Through 12 months	Data will be collected to characterize heart failure hospitalizations within the first 12 months after device implant
Lead-related complications	Through 12 months	Data will be collected to characterize lead-related complications

Trial Locations

Locations (8)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Icahn School of Medicine at Mount Sinai & Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Geisinger Wyoming Valley Medical Center; 🇺🇸 Wilkes-Barre, Pennsylvania, United States

Health Research Institute Hospital La Fe; 🇪🇸 Valencia, Spain

Lund University; 🇸🇪 Lund, Sweden