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New pacing technique aims to cut heart failure risk

NCT ID NCT07279870

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a newer pacing method called Conduction System Pacing (CSP) against standard right ventricular pacing in 1,260 adults with heart block. The goal is to see if CSP reduces heart failure events, hospitalizations, and need for additional procedures, while also improving quality of life and being cost-effective. Participants are randomly assigned to one of the two pacing approaches.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Conduction System Pacing (CSP) procedure vs. standard Right Ventricular (RV) pacing procedure
What this could lead to
If CSP works better, it could become the new standard for pacing, reducing heart failure hospitalizations and improving daily life for people with heart block.
What could go wrong
This is a large trial but still early in testing. CSP is a newer, more complex procedure that may not always be successful or could have higher risks during implantation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients with AV block in either sinus rhythm (SR) or permanent atrial tachycardia/atrial fibrillation (AT/AF), or with slow AV conduction during AT/AF, or undergoing AV node ablation + ventricular stimulation * male and female * acquired informed consent Exclusion Criteria: * Class I indication to Implantable Cardioverter Defibrillator (ICD) or to Cardiac Resynchronization Therapy (CRT) * Ejection Fraction \< 35% * Life expectancy \< 2 years * Participation in another clinical trial which might impact on the study outcome * Pregnancy, except as "In the event of an ongoing pregnancy, the doctor and patient will jointly assess, on a case-by-case basis and in the best interests of the patient, whether to propose participation in the study (random assignment to one of the two stimulation techniques) or to proceed as per clinical practice (assignment to one of the two stimulation techniques by the doctor). A screening log file of all eligible patients will be recorded, detailing the reason/s for non-randomization."

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APSS Trento - Ospedale S. Maria del Carmine di Rovereto

    NOT_YET_RECRUITING

    Trento, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    NOT_YET_RECRUITING

    Milan, Italy

  • Azienda Ospedal iera "Card. G. Panico"

    NOT_YET_RECRUITING

    Bari, Italy

  • Azienda Ospedaliera Santa Maria della Misericordia

    NOT_YET_RECRUITING

    Perugia, Italy

  • Azienda Ospedaliero-Univeritaria di Palermo - Policlinico Giaccone

    NOT_YET_RECRUITING

    Palermo, Italy

  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

    NOT_YET_RECRUITING

    Novara, Italy

  • Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico -San Marco"

    NOT_YET_RECRUITING

    Catania, Italy

  • Azienda Ospedaliero-Universitaria di Ferrara

    RECRUITING

    Ferrara, Italy

  • Azienda Ospedaliero-Universitaria di Parma

    NOT_YET_RECRUITING

    Parma, Italy

  • Azienda Sanitaria locali di Asti Ospedale Cardinal Massaia

    NOT_YET_RECRUITING

    Novara, Italy

  • Città delle Salute e della Scienza di Torino. Dipartimento Cardiovascolare e Toracico

    NOT_YET_RECRUITING

    Torino, Italy

  • IRCCS AOUBO Policlinico di Sant'orsola

    RECRUITING

    Bologna, 40138, Italy

  • Ospedale di Rovigo Aulss 5 Polesana

    NOT_YET_RECRUITING

    Rovigo, Italy

  • Policlinico Casilino

    NOT_YET_RECRUITING

    Roma, Italy

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