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New heart procedure could ease dual burden of heart failure and AF

NCT ID NCT05029570

Disease control Sponsor: Daniel Rodríguez Muñoz Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is testing whether a combination of a special pacemaker (conduction system pacing) and a targeted heart ablation can help people with both heart failure and permanent atrial fibrillation. About 334 participants will be randomly assigned to either receive the procedure or continue with standard heart-rate control medications. The goal is to see if the procedure reduces deaths, hospitalizations, and worsening heart failure over three years.

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 (pacemaker) and Atrioventricular Node Ablation
What this could lead to
If successful, this could offer a more effective treatment strategy for people with heart failure and atrial fibrillation, potentially reducing hospitalizations and improving survival.
What could go wrong
This is a mid-stage trial, so results are not yet proven. The procedure carries risks like bleeding, infection, or heart damage, and may not work better than standard medication.

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 334 people

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

Started

Apr 2022

Expected to finish

Sep 2030

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: * Permanent atrial fibrillation * At least one episode of hospitalisation due to heart failure in the previous 12 months. * Left ventricular ejection fraction \> 40% * Average resting heart rate ≤ 110 beats per minute * NT-proBNP ≥ 900 pg/ml in the 30 days prior to enrollment * Age ≥ 18 years * Capacity to understand the nature of the study, legal ability and willingness to give informed consent. Exclusion Criteria: * Severe frailty (Clinical Frailty Scale ≥ 7) or comorbidity reducing life expectancy to \< 12 months. * Acute heart failure at the time of enrollment or systolic blood pressure \< 80 mmHg in the absence of inotropic agents. * Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 20 ml/1,73 m2 * Severe mitral or aortic valvular heart disease * Anaemia (Haemoglobin \< 10 g/dl) * Morbid obesity (BMI ≥ 35) * Severe Chronic Obstructive Pulmonary Disease (Gold ≥ 3) * Presence of a different indication for pacing of implantable cardioverter-defibrillator (ICD) * Obstructive hypertrophic cardiomyopathy * Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others) * Simultaneous participation in a different trial

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Conditions

The condition(s) this trial relates to.

atrial fibrillation heart failure

As listed by the trial registrant

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

Atrial fibrillation Heart failure

How to take part

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

  1. The places running it

    1 site. 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

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

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