Bradyarrhythmia, Heart Failure
Conditions
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)
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.
Interventions
OTHERData 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.
Sponsors
University of Chicago
Biotronik SE & Co. KG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| QRS duration measured by electrocardiography after implant | Month 0, pre discharge | Data will be collected on QRS duration (milliseconds) after implant procedure |
| 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 |
| 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 |
| Procedure-related complications | Through 12 months | Data will be collected to characterize procedure-related complications |
| Changes in left ventricular ejection fraction | Through 12 months | Data will be collected to characterize changes in left ventricular ejection fraction |
| Changes in chamber dimension | Through 12 months | Data will be collected to characterize changes in chamber dimension |
| Heart failure hospitalizations | Through 12 months | Data will be collected to characterize heart failure hospitalizations within the first 12 months after device implant |
| Any-cause mortalities | Through 12 months | Data will be collected to characterize any-cause mortalities within the first 12 months after device implant |
| Sustained ventricular arrhythmia occurrences | Through 12 months | Data will be collected to characterize sustained ventricular arrhythmia occurrences |
| System-related complications | Through 12 months | Data will be collected to characterize system-related complications |
| Lead-related complications | Through 12 months | Data will be collected to characterize lead-related complications |
Countries
Netherlands, Spain, Sweden, United States
Contacts
PRINCIPAL_INVESTIGATORGaurav A Upadhyay, MD
University of Chicago
Outcome results
None listed