CompletedNot Applicable

Conduction System Pacing Versus Biventricular Pacing for Cardiac ResYNChronization

Slovenia62 participantsStarted 2022-01-10

Plain-language summary

Cardiac resynchronization therapy (CRT) with biventricular pacing (BiV) is the cornerstone treatment for heart failure patients with ventricular dyssynchrony. Recently, a new concept, conduction system pacing (CSP) with permanent pacing, including His bundle pacing and left bundle branch pacing, has been proposed as a potential alternative to conventional BiV-CRT. The prospective, randomized trial will compare echocardiographic, electrocardiographic, and clinical effects of CSP versus conventional BiV pacing in heart failure patients with reduced ejection fraction (LVEF ≤ 35%), sinus rhythm, and left bundle branch block. Patients will be randomized to either CSP or biventricular pacing study group and followed up for at least 6 months. The study will explore whether CSP is non-inferior to BiV pacing in echocardiographic, electrocardiographic, and clinical outcomes.

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

. Sinus rhythm and complete left bundle branch block according to Strauss criteria
. LVEF ≤35%
. NYHA class II-III
. Optimal medical heart failure therapy for at least 3 months before enrollment
. The patient is able to understand and willing to provide a written informed consent
. 18 years of age or older

Exclusion criteria

. Mechanical tricuspid valve replacement

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 in left ventricular volume

Timeframe: acute after the procedure, 1 month, 6 months, 12 months

Change in left ventricular ejection fraction

Timeframe: acute procedure, 1 month, 6 months, 12 months

Difference in Heart Failure Class

Timeframe: 6 months

Difference in pro-BNP value

Timeframe: 6 months

Difference in 6-minute walk test distance

Timeframe: 6 months

Difference in the EQ-5D index

Timeframe: 6 months

Trial details

NCT IDNCT05155865

SponsorUniversity Medical Centre Ljubljana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-28

View on ClinicalTrials.gov More Dilated Cardiomyopathy with Conduction Defect 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.

Inclusion criteria

. Sinus rhythm and complete left bundle branch block according to Strauss criteria
. LVEF ≤35%
. NYHA class II-III
. Optimal medical heart failure therapy for at least 3 months before enrollment
. The patient is able to understand and willing to provide a written informed consent
. 18 years of age or older

Exclusion criteria

. Mechanical tricuspid valve replacement

What they're measuring

Change in left ventricular volume

Timeframe: acute after the procedure, 1 month, 6 months, 12 months

Change in left ventricular ejection fraction

Timeframe: acute procedure, 1 month, 6 months, 12 months

Difference in Heart Failure Class

Timeframe: 6 months

Difference in pro-BNP value

Timeframe: 6 months

Difference in 6-minute walk test distance

Timeframe: 6 months

Difference in the EQ-5D index

Timeframe: 6 months