TerminatedNot Applicable

Adaptive Cardiac Resynchronization Therapy in Patients With RBBB

Stopped: Low enrollment

United States5 participantsStarted 2017-09-15

Plain-language summary

This study will address whether acute adaptive RV pacing in sinus rhythm patients with severe LV systolic dysfunction and RBBB is superior to no ventricular pacing, and is as effective as echocardiographically optimized biventricular (BIV) pacing based on Medtronic ECG belt and cardiac performance as assessed by the echocardiographic parameters of RV and LV function.

Who can participate

Age range

18 Years – 89 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: Included patients will have: * sinus rhythm or isolated atrial pacing * LV systolic dysfunction (EF \<35% at time of device implant) * AV conduction \<250 ms, RBBB, and * have an implanted CRT device based on the ACC/AHA/HRS guidelines (2, 18) or will have a CRT device implanted during the study enrollment per ACC/AHA/HRS guidelines (2). Exclusion Criteria: * atrial fibrillation * atrial flutter * atrial tachycardia * AV delay \> 250 ms * sinus tachycardia with resting heart rate at time of the study 100 bpm * frequent APCs (\> 25% of the total beats/min) or PVCs (\>20% of the total beats/min), or * patients with EF \> 40% at time of enrollment (if LV systolic function was found to be improved from time of implant).

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

Effectiveness of adaptive Right Ventricular (RV) pacing

Timeframe: 1 hour

Trial details

NCT IDNCT05936294

SponsorHenry Ford Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-31

View on ClinicalTrials.gov More Right Bundle-Branch Block trials