TerminatedNot Applicable

Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure (The SPARK Trial)

Stopped: PI left the institution

United States6 participantsStarted 2016-02-01

Plain-language summary

This clinical study has been designed to test whether a new pacing therapy would lead to improvement in heart function, symptoms and quality of life in a specific group of heart failure patients. This group has a unique electrical conduction problem (Right Bundle Branch Block) that did not respond well to the current available pacing therapy.

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: * Cardiomyopathy; ischemic or non-ischemic on optimal medical therapy per current heart failure treatment guidelines for at least 3 months. * LVEF \< 35% by trans-thoracic echocardiogram assessment * Prior implantation of pacemaker/defibrillator with at least an atrial and RV mid septal lead. Atrial lead can be waived if RV lead has atrial sensing capabilities\* * Normal sinus rhythm at enrollment * RBBB with QRS duration \>120 msec on 12 lead surface EKG. * PR interval \<250 msec on 12 lead surface EKG * Subjects with biventricular pacemaker/ICD will be eligible for enrollment if their LV lead pacing function has been turned off by the subject's primary cardiologist prior to study enrollment for at least 3 months (this could be due to lead malfunction or the decision to deactivate the LV pacing therapy for any reason per primary cardiologist discretion) Exclusion Criteria: * Age younger than 18 years old * Pregnancy * Acute Myocardial infarction within 6 months of entry into the study * Inotrope dependent heart failure condition * Left ventricular assist device or heart transplantation * Any other known conditions other than heart failure that could limit survival to \< 6 months. * Atrial fibrillation or flutter burden \>10% of the time within the last 6 months * Atrioventricular node disease that requires ventricular pacemaker support \>10% of the time

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

Change of LV Ejection Fraction Compared to Baseline

Timeframe: Baseline to 3 months

Trial details

NCT IDNCT02441101

SponsorBarry London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-11

Results submitted2023-12-22

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