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

NCT ID NCT05119231

Symptom relief Sponsor: University of Leipzig 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 1 time

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.

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

262 people

The number who actually took part.

Started

Nov 2021

Expected to finish

Nov 2026

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: 1. Patients with symptomatic atrial fibrillation scheduled for pulmonary vein isolation 2. Class I or class IIa indication for pulmonary vein isolation by current guidelines 3. Age ≥ 18 years 4. Written informed consent Exclusion Criteria: 1. History of previous pulmonary vein isolation or surgical treatment of atrial fibrillation 2. Reversible causes of atrial fibrillation (e. g. thyroid disorder, acute alcohol intoxication, recent major surgical procedures, trauma or acute infection) 3. Moderate or severe valvular heart disease 4. CHA2DS2-VASc-Score =0 (males) or 1 (females) or contraindication to oral anticoagulation 5. Acute coronary syndrome, percutaneous coronary intervention, valve surgery or percutaneous intervention or cardiac bypass surgery and stroke within the last 3 months 6. Reduced left ventricular ejection fraction \< 35% 7. Hypertrophic obstructive cardiomyopathy 8. Medical conditions limiting the expected survival to \< 1 year 9. Participation in any other randomized controlled trial 10. Women of childbearing potential without appropriate contraceptive measures (oral contraceptives, vaginal ring, intrauterine devices, implanon, injections, partner with vasectomy) pregnant woman or woman with desire for children 11. Any condition that - in the opinion of the investigator - may prevent the subject from adhering to the study protocol (e.g. history of non-compliance, drug addiction) 12. Subjects under legal supervision or guardianship 13. Unable to give informed consent

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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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