Heart procedure put to the test: real relief or placebo?

NCT ID NCT05119231

Ongoing Symptom relief Sponsor: University of Leipzig Source: ClinicalTrials.gov ↗

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

Summary

This study compares a common heart procedure called pulmonary vein isolation (PVI) to a fake (sham) version to see if it truly reduces symptoms of atrial fibrillation. About 262 people with symptomatic AF will be randomly assigned to receive either the real procedure or a sham procedure that mimics it. The goal is to measure changes in symptoms and quality of life after 6 months.

What this could mean

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

Active substance: catheter ablation (pulmonary vein isolation)
What this could lead to: If successful, this could confirm that catheter ablation genuinely improves symptoms and quality of life for people with atrial fibrillation, beyond a placebo effect.
What could go wrong: This is a relatively small trial (262 participants) and the sham procedure involves risks like sedation and puncture. The results may not apply to all AF patients, and symptom improvement could still be partly placebo.

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation heart disorder

As listed by the trial registrant

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

ATRIAL FIBRILLATION

Contacts and locations

Locations

Department of Cardiology, Silesian Center for Heart Diseases

Zabrze, Poland
German Heart Center of Charité University Medicine, Standort Charité Mitte

Berlin, State of Berlin, Germany
German Heart Center of Charité University Medicine, Standort DHZB

Berlin, State of Berlin, Germany
Heart Center Dresden University Hospital

Dresden, Saxony, 01307, Germany
Herzzentrum Leipzig

Leipzig, Germany
Regiomed Klinikum

Coburg, Bavaria, 96450, Germany
University Hospital Gießen

Giessen, Hesse, Germany
Universitätsklinikum Leipzig

Leipzig, Germany
Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

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