Testing a heart rhythm device after heart surgery

Plain-English translation of NCT04804748 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated August 2026 · How we translate trials

What is this trial?

This trial is testing a device called DefiPace, which uses low-energy electrical pulses to treat and prevent abnormal heart rhythms (atrial fibrillation) that can develop after heart surgery. The study will compare how patients do with standard care versus those who receive this new device. The goal is to see if DefiPace can safely and effectively restore normal heart rhythm and prevent these rhythm problems from coming back.

Abnormal heart rhythms are a common complication after heart surgery and can cause symptoms like irregular heartbeat, fatigue, and in some cases, serious health problems. Doctors want to find safer and more effective ways to treat and prevent this condition, and this new device may offer a gentler alternative to current treatments.

Do you qualify?

You likely qualify if…

you are at least 18 years old
you are scheduled for elective heart surgery (bypass and/or valve surgery)
if you're having bypass surgery only, you are at least 70 years old
if you're having valve surgery, you are at least 60 years old
you have never been diagnosed with atrial fibrillation before your surgery

You likely don't qualify if…

you have a history of atrial fibrillation (any type) before surgery
you already have a permanent pacemaker or defibrillator
you've had a stroke in the last 3 months
you have a current or past infection of the heart lining (endocarditis)
you are pregnant at the time of surgery

What participation looks like

If you join this trial, you'll undergo your planned heart surgery as scheduled. Depending on which group you're in, either standard post-surgery care will be documented, or you may receive the DefiPace device to help manage your heart rhythm. The research team will collect information about your recovery while you're in the hospital, and if you develop an abnormal heart rhythm after surgery, you'll receive a follow-up phone call 30 days after discharge to check on how you're doing.

AI-generated summary from trial data · Aug 3, 2026 · Not medical advice

Trial locations(10 sites)

Austria

Medical University of Vienna, Vienna

Germany

Universitätsklinikum Erlangen, Erlangen, Bavaria

Klinikum Nürnberg, Nuremberg, Bavaria

University Hospital of Würzburg, Würzburg, Bavaria

Oldenburg Hospital AöR / Medical Campus University of Oldenburg, Oldenburg, Lower Saxony