CompletedNot Applicable

Conduction System Stimulation to Avoid Left Ventricle Dysfunction

Spain75 participantsStarted 2019-09-30

Plain-language summary

The aim of the study is to demonstrate that conduction system pacing (CSP) can preserve a normal ventricular function compared to right ventricular apical pacing (RVAP) in patients with pre-implant preserved left ventricular ejection fraction (LVEF) and a high burden of expected ventricular pacing due to atrioventricular conduction block (AV block). After informed consent signature, patients with high degree AV block and normal LVEF will be randomized to permanent pacemaker stimulation with CSP vs RVAP. All the patients have a complete evaluation before the procedure and at 3 and 6 months follow-up.

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

. Age of 18 years or more
. Preserved or mild deteriorated LVEF (Simpson \>40%) assessed by a recent (\<1 month before implantation) transthoracic echocardiography.
. Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (\>50%).
. Live expectancy of more than 6 months and capability to understand the protocol, signing the informed consent form and accomplish the follow-up.

Exclusion criteria

. Indication for implantable cardioverter defibrillator device.
. Patients with previous LVD and a recovered LVEF

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

Delta-LVEF at 6 months

Timeframe: 6 months

Trial details

NCT IDNCT06026683

SponsorParc de Salut Mar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-02

View on ClinicalTrials.gov More Atrioventricular Block, Second and Third Degree trials