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New heart-rhythm fix after surgery: gentler shocks, faster recovery?

NCT ID NCT04804748

Disease control Sponsor: Institut für Pharmakologie und Präventive Medizin 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study looks at a new way to treat an irregular heartbeat (atrial fibrillation) that can happen after heart surgery. It uses low-energy electrical shocks and special pacing to try to restore a normal rhythm. The goal is to see if this approach is safe and effective, and if it helps patients spend less time in the ICU. About 450 adults having planned heart surgery will take part.

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

About 450 people

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

Started

Mar 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Who is studied

Phase A Approximately 150 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) Phase B Approximately 300 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) with planned TMA implantation.

Ages

18 years and older

Sex

Anyone

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: * Patient is scheduled to undergo elective open chest cardiac surgery (bypass and / or valve surgery) * Patient is at least 18 years old * Patient with isolated bypass surgery is at least 70 years old * Patient with valve surgery is at least 60 years old * Patient provides written informed consent prior to the procedure * Phase B only: patient is scheduled for TMA implantation during the elective cardiac surgery and is potentially eligible for DefiPace use Exclusion Criteria: * Clinical history of either permanent, persistend or paroxysmal atrial fibrillation * Permanent pacemaker/defibrillator, other intra-cardiac active implanted electronic devices * Minimally-invasive surgery * Recent stroke within the last 3 months * A history of or current endocarditis * Pregnacy at the time of surgery

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Post-operative atrial fibrillation poaf

How to take part

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

  1. The places running it

    10 sites in 2 countries. 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

  • Albert-Ludwigs-Universitaet Freiburg

    RECRUITING

    Freiburg im Breisgau, 79106, Germany

  • Hannover Medical School

    RECRUITING

    Hanover, 30625, Germany

  • Heart Center Dresden GmbH University Hospital

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Klinikum Nürnberg

    RECRUITING

    Nuremberg, Bavaria, 90419, Germany

  • Medical University of Vienna

    RECRUITING

    Vienna, 1090, Austria

  • Oldenburg Hospital AöR / Medical Campus University of Oldenburg

    RECRUITING

    Oldenburg, Lower Saxony, 26133, Germany

  • University Hospital Jena

    RECRUITING

    Jena, 07747, Germany

  • University Hospital Ulm

    RECRUITING

    Ulm, 89081, Germany

  • University Hospital of Würzburg

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

  • Universitätsklinikum Erlangen

    RECRUITING

    Erlangen, Bavaria, 91054, Germany

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