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Same-Day pacemaker implant: a game changer for heart failure patients?

NCT ID NCT05142293

Symptom relief Sponsor: Biotronik SE & Co. KG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 2 times

Summary

This study looks at whether people with heart failure can safely receive a special pacemaker (CRT-P) and go home the same day, instead of staying overnight in the hospital. Researchers are tracking serious side effects for six months after the procedure and checking if patients' quality of life improves. The goal is to make the process more convenient and efficient for patients.

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.

Participants

354 people

The number who actually took part.

Started

Dec 2021

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Only patients with an indication for a CRT-P system according to current clinical practice and who are already planned to be implanted with a CRT system according to the investigator's decision may be enrolled in this submodule.

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: * Planned de novo implantation or upgrade to a Cardiac Resynchronization Therapy Pacemaker system according to the intended use * Patient is able to understand the nature of the registry and has provided written informed consent for BIO\|STREAM.HF (heart failure registry) and the registry-based trial BIO\|OEDIPE.CRT-P * Patient enrolled in BIO\|STREAM.HF (heart failure registry) Exclusion Criteria: * Patients in emergency situation or without medical assessment before hospitalisation for implantation * Patients previously implanted with an implantable cardiac defibrillator system * Patients with an implantable cardiac defibrillator indication * Patients planned to be implanted with an epicardial left ventricular lead (not implanted via the coronary sinus) * Patients planned to be implanted with His bundle pacing system

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

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

Heart failure

Contacts and locations

Locations

  • CH Bretagne Sud

    Lorient, France

  • CH Saint Lô

    Saint-Lô, France

  • CH Valence

    Valence, France

  • CHRU de Tours - Hôpital Trousseau

    Tours, France

  • CHU Brest

    Brest, France

  • CHU Caen

    Caen, France

  • CHU La Timone

    Marseille, France

  • CHU Montpellier

    Montpellier, France

  • CHU Saint Etienne

    Saint-Etienne, France

  • Clinique Les Fontaines

    Melun, France

  • Clinique Pasteur

    Toulouse, France

  • Clinique du Millénaire

    Montpellier, France

  • GCS Centre de Cardiologie du Pays Basque

    Bayonne, France

  • Hôpital La Pitié-Salpêtrière

    Paris, France

  • Hôpital Louis Pasteur

    Chartres, France

  • Hôpital Privé Jacques Cartier

    Massy, France

  • Hôpital Privé du Confluent

    Nantes, France

  • Hôpital Saint Philibert

    Lomme, France

  • Nouvel Hôpital Civil

    Strasbourg, France

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