Heart Failure Clinical Trial
Official title:
Conduction System Pacing International Registry (CONSPIRE)
NCT number | NCT04831125 |
Other study ID # | IRB20-1601 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 4, 2021 |
Est. completion date | April 2025 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Chicago | Biotronik SE & Co. KG |
United States, Netherlands, Spain, Sweden,
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 |
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