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Conduction System Pacing International Registry (CONSPIRE Registry)

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ClinicalTrials.gov Identifier: NCT04831125
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : June 8, 2022
Sponsor:
Collaborator:
Biotronik SE & Co. KG
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Bradyarrhythmia Heart Failure Other: Data collection

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Conduction System Pacing International Registry (CONSPIRE Registry)
Actual Study Start Date : April 4, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Group/Cohort Intervention/treatment
Individuals receiving conduction system pacing 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.




Primary Outcome Measures :
  1. Implant characteristics [ Time Frame: 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)

  2. QRS duration measured by electrocardiography at baseline [ Time Frame: Baseline, within 1 month prior to procedure ]
    Data will be collected on QRS duration (milliseconds) prior to implant

  3. QRS morphology captured by surface electrocardiography at baseline [ Time Frame: 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

  4. QRS duration measured by electrocardiography after implant [ Time Frame: Month 0, pre discharge ]
    Data will be collected on QRS duration (milliseconds) after implant procedure

  5. QRS morphology captured by surface electrocardiography after implant [ Time Frame: 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

  6. Procedure-related complications [ Time Frame: Through 12 months ]
    Data will be collected to characterize procedure-related complications

  7. Changes in left ventricular ejection fraction [ Time Frame: Through 12 months ]
    Data will be collected to characterize changes in left ventricular ejection fraction

  8. Changes in chamber dimension [ Time Frame: Through 12 months ]
    Data will be collected to characterize changes in chamber dimension

  9. Heart failure hospitalizations [ Time Frame: Through 12 months ]
    Data will be collected to characterize heart failure hospitalizations within the first 12 months after device implant

  10. Any-cause mortalities [ Time Frame: Through 12 months ]
    Data will be collected to characterize any-cause mortalities within the first 12 months after device implant

  11. Sustained ventricular arrhythmia occurrences [ Time Frame: Through 12 months ]
    Data will be collected to characterize sustained ventricular arrhythmia occurrences

  12. System-related complications [ Time Frame: Through 12 months ]
    Data will be collected to characterize system-related complications

  13. Lead-related complications [ Time Frame: Through 12 months ]
    Data will be collected to characterize lead-related complications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04831125


Contacts
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Contact: Tiffany Hart 773-702-0535 thart@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: Kevin Vernooy, MD    +31(0)433877095    kevin.vernooy@mumc.nl   
Principal Investigator: Kevin Vernooy, MD         
Sponsors and Collaborators
University of Chicago
Biotronik SE & Co. KG
Investigators
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Principal Investigator: Gaurav A Upadhyay, MD University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04831125    
Other Study ID Numbers: IRB20-1601
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
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)
Additional relevant MeSH terms:
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Bradycardia
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes