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Heart rhythm showdown: which procedure keeps seniors out of hospital?

NCT ID NCT04906668

Disease control Sponsor: St. Josefs-Hospital Wiesbaden GmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two procedures for people aged 75 and older with persistent atrial fibrillation (an irregular heartbeat). One group gets a pacemaker plus ablation of the heart's electrical node, while the other gets pulmonary vein isolation using cryoenergy. The goal is to see which approach reduces hospital stays and improves quality of life. The trial involves 196 participants across multiple centers.

What this could mean

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

What this could lead to
If successful, this could show which procedure better reduces hospitalizations and improves quality of life for elderly patients with persistent atrial fibrillation.
What could go wrong
This is a relatively small trial (196 participants) and results may not apply to all elderly patients. Both procedures carry risks like bleeding or infection, and one group may need additional treatments.

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

About 196 people

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

Started

May 2021

Expected to finish

Apr 2027

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

75 to 99 years

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: * Persistent AF according to current ESC guideline (2020) * Symptoms EHRA classification II - IV despite guideline indicated medical therapy * Age ≥ 75 years * Capability of giving written informed consent Exclusion Criteria: * impaired systolic left ventricular function (ejection fraction \< 50%) * High-grade (III°) left cardiac valvular disease * pre-implanted pacemaker * bradycardia-indication for pacemaker * Surgical coronary revascularization (within the last 90 days) or current triple therapy after stent PCI * contraindication for PVI or pacemaker-implantation * contraindication for oral anticoagulation * body-mass-index BMI \> 40 kg/m2 * inability to give written informed consent * concomitant participation in another registered trial * life expectancy \< 12 months * reversible cause of AF (e.g. thyrotoxicosis, alcohol ingestion)

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation

Contacts and locations

Locations

  • Asklepios Klinik St. Georg

    Hamburg, Germany

  • Ev. Krankenhaus Hagen-Haspe

    Hagen, Germany

  • Kerckhoff-Klinik Bad Nauheim

    Bad Nauheim, Germany

  • Klinikum Fürth

    Fürth, Germany

  • Krankenhaus Landshut-Achdorf

    Landshut, Germany

  • St. Josefs-Hospital Wiesbaden GmbH

    Wiesbaden, 65189, Germany

  • Universitätsklinikum Essen

    Essen, Germany

  • Universitätsklinikum Frankfurt am Main

    Frankfurt, Germany

  • Universitätsklinikum Innsbruck

    Innsbruck, Austria

  • Universitätsklinikum Münster

    Münster, Germany

  • Vivantes Klinikum am Urban

    Berlin, Germany

  • Westpfalz-Klinikum Kaiserslautern

    Kaiserslautern, Germany

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