CompletedNot Applicable

Electrical and Mechanical Activation in PAcing The His Bundle Conduction sYstem

Italy15 participantsStarted 2021-02-01

Plain-language summary

In recent years, the finding of long-term deleterious effects of right ventricular pacing (RVP) has led to an ongoing search for alternative pacing sites such as His bundle stimulation. The depolarization of the ventricles through the His-Purkinje cardiac conduction system seems to represent an ideal physiological approach to ventricular pacing, capable of engaging the normal conduction pathways and determining synchronous ventricular activation. However, there are still no clinical studies that have evaluated the electromechanical functions of the left ventricle with His bundle pacing (HBP) identified after electroanatomical reconstruction with 3D mapping system. Investigators aimed to compare the electromechanical effects on left ventricle of HBP, compared to RVP stimulation and to spontaneous rhythm of each patient.

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: * Patients with indication of class I or class IIa for permanent pacemaker implantation, in accordance with the guidelines of the European Society of Cardiology on cardiac pacing * Age ≥ 18 years * Written consent Exclusion Criteria: * Patients unable to express informed consent * Pregnancy * Severe mitro-aortic valve disease * Left ventricular ejection fraction ≤ 35%

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

Evaluate the electrocardiographic differences of HBP, obtained by electroanatomical reconstruction with 3D mapping system, compared to the RVP and the patient's spontaneous rhythm.

Timeframe: 24 hours after implantation

Evaluate the echocardiographic differences of HBP, obtained by electroanatomical reconstruction with 3D mapping system, compared to the RVP and the patient's spontaneous rhythm.

Timeframe: 24 hours after implantation

Trial details

NCT IDNCT05222672

SponsorUniversity Hospital of Ferrara

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-01-07

View on ClinicalTrials.gov More Pacemaker DDD 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.

What they're measuring

Evaluate the electrocardiographic differences of HBP, obtained by electroanatomical reconstruction with 3D mapping system, compared to the RVP and the patient's spontaneous rhythm.

Timeframe: 24 hours after implantation

Evaluate the echocardiographic differences of HBP, obtained by electroanatomical reconstruction with 3D mapping system, compared to the RVP and the patient's spontaneous rhythm.

Timeframe: 24 hours after implantation