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Left Ventricular Septal Pacing: Potential Application for Cardiac Resynchronization Therapy

Netherlands30 participantsStarted 2017-11-23

Plain-language summary

In cardiac resynchronization therapy (CRT), biventricular pacing is performed by pacing the right ventricle (RV) and epicardium of the left ventricular (LV) postero-lateral wall. A significant proportion of apparently suitable patients fail to benefit from CRT. One of the problems of CRT is proper positioning and fixation of the LV pacing lead in the coronary vein. LV septal pacing may be a good alternative for BiV pacing in patients with an indication for CRT.

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: * Chronic heart failure with NYHA functional class II-IV * Left ventricular ejection fraction (LVEF) \< 35% * LBBB and QRS duration ≥ 130 ms or non-LBBB and QRS duration ≥ 150 ms * In sinus rhythm * Optimal pharmacological therapy Exclusion Criteria: * Persistent atrial fibrillation * ≥ 2 premature ventricular complexes on standard 12-lead electrocardiogram (ECG) * Age \< 18 years * Incapable of giving informed consent * Moderate to severe aortic valve stenosis * Peripheral vascular disease

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

Acute hemodynamic effect (LV dP/dtmax) of the best LV septal pacing side and conventional BiV pacing.

Timeframe: The outcome measure will be assessed during the CRT implantation procedure (the total procedure time will increase 45 to 60 minutes).

Trial details

NCT IDNCT03415945

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-23

Contact for this trial

Floor Salden, MD

+31-43-3884520 floor.salden@mumc.nl

View on ClinicalTrials.gov More Heart Failure trials