Conduction System Pacing International Registry (CONSPIRE)

Heart Failure Clinical Trial

Official title:

Conduction System Pacing International Registry (CONSPIRE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04831125
• Other study ID #: IRB20-1601
• Status: Recruiting
• Start date: April 4, 2021
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: University of Chicago
• Contact: Shahram Sarrafi
• Phone: (773) 702-5877
• Email: ssarrafi1[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradyarrhythmia
• Bradycardia
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht
Spain	Health Research Institute Hospital La Fe	Valencia
Sweden	Lund University	Lund
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	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Arizona	Tucson	Arizona
United States	Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Biotronik SE & Co. KG

Countries where clinical trial is conducted

United States,  Netherlands,  Spain,  Sweden, 

Outcome

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