CompletedNot Applicable

Evaluation of Electrical and Hemodynamic Effects of Different Pacing Strategies in CRT Candidates

China28 participantsStarted 2024-06-03

Plain-language summary

Heart failure patients with delayed electrical activation of the heart often benefit from cardiac resynchronization therapy (CRT). However, traditional CRT using biventricular pacing is not effective in all patients. This study aims to evaluate the acute effects of pacing at different sites within the heart's conduction system-including His bundle pacing, deep septal pacing, left ventricular septal pacing, non-selective left bundle branch pacing, and selective left bundle branch pacing. We will assess how these pacing strategies improve electrical synchrony and heart function by analyzing ECG parameters, such as QRS duration and QRS area, and measuring hemodynamic response using left ventricular pressure changes. The goal is to identify which pacing site provides the best improvement in heart performance. The study includes patients with left bundle branch block or intraventricular conduction delay, reduced heart function (ejection fraction \<35%), and prolonged QRS duration (\>150 ms). This research may help improve the effectiveness of pacing therapy in heart failure patients who are not responding well to current CRT methods.

Who can participate

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: NYHA class I to ambulatory IV despite optimized medical therapy for ≥3 months, LVEF ≤35%, and sinus rhythm with LBBB. LBBB was defined as QRS duration ≥130 ms, QS or rS in lead V1, broad/notched R waves in leads I, aVL, V5-V6, and absence of q waves in V5-V6 Exclusion Criteria: second- or third-degree AV block, frequent PVCs, moderate-to-severe aortic stenosis, LV thrombus, or significant 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

QRSd

Timeframe: within 30 minutes per patient

QRSa

Timeframe: within 30 minutes per patient

Hemodynamic Evaluation

Timeframe: within 30 minutes per patient

Trial details

NCT IDNCT07032064

SponsorShanghai Zhongshan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-20

View on ClinicalTrials.gov More Heart Failure trials

Plain-language summary

Who can participate

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.