CompletedNot Applicable

Conduction System Pacing International Registry (CONSPIRE)

United States, Netherlands, Spain383 participantsStarted 2021-04-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Implant characteristics

Timeframe: Month 0, during procedure

QRS duration measured by electrocardiography at baseline

Timeframe: Baseline, within 1 month prior to procedure

QRS morphology captured by surface electrocardiography at baseline

Timeframe: Baseline, within 1 month prior to procedure

QRS duration measured by electrocardiography after implant

Timeframe: Month 0, pre discharge

QRS morphology captured by surface electrocardiography after implant

Timeframe: Month 0, pre discharge

Procedure-related complications

Timeframe: Through 12 months

Changes in left ventricular ejection fraction

Timeframe: Through 12 months

Trial details

NCT IDNCT04831125

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02-05

View on ClinicalTrials.gov More Bradyarrhythmia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Implant characteristics

Timeframe: Month 0, during procedure

QRS duration measured by electrocardiography at baseline

Timeframe: Baseline, within 1 month prior to procedure

QRS morphology captured by surface electrocardiography at baseline

Timeframe: Baseline, within 1 month prior to procedure

QRS duration measured by electrocardiography after implant

Timeframe: Month 0, pre discharge

QRS morphology captured by surface electrocardiography after implant

Timeframe: Month 0, pre discharge

Procedure-related complications

Timeframe: Through 12 months

Changes in left ventricular ejection fraction

Timeframe: Through 12 months