Clinical trial NCT04831125: Conduction System Pacing International Registry (CONSPIRE)
Official title: Conduction System Pacing International Registry (CONSPIRE)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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)
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Biotronik SE & Co. KG
First posted: 2021-04-05
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implant characteristics
timeFrame: Month 0, during procedure
measure: QRS duration measured by electrocardiography at baseline
timeFrame: Baseline, within 1 month prior to procedure
measure: QRS morphology captured by surface electrocardiography at baseline
timeFrame: Baseline, within 1 month prior to procedure
measure: QRS duration measured by electrocardiography after implant
timeFrame: Month 0, pre discharge
measure: QRS morphology captured by surface electrocardiography after implant
timeFrame: Month 0, pre discharge
measure: Procedure-related complications
timeFrame: Through 12 months
measure: Changes in left ventricular ejection fraction
timeFrame: Through 12 months
measure: Changes in chamber dimension
timeFrame: Through 12 months
measure: Heart failure hospitalizations
timeFrame: Through 12 months
measure: Any-cause mortalities
timeFrame: Through 12 months
measure: Sustained ventricular arrhythmia occurrences
timeFrame: Through 12 months
measure: System-related complications
timeFrame: Through 12 months
measure: Lead-related complications
timeFrame: Through 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai & Mount Sinai Hospital
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Valencia
country: Spain
facility: Health Research Institute Hospital La Fe
city: Lund
country: Sweden
facility: Lund University
Study officials:
affiliation: University of Chicago
name: Gaurav A Upadhyay, MD
role: PRINCIPAL_INVESTIGATOR
References: