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New heart procedure aims to improve rhythm control in persistent AF patients

NCT ID NCT05922917

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests two different ablation techniques using a new, safer method called pulsed-field ablation (PFA) in 300 adults with persistent atrial fibrillation (a type of irregular heartbeat). One group gets standard vein isolation, while the other gets additional targeted burns in the heart. The goal is to see which approach better prevents the return of irregular heartbeats over 12 months.

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 300 people

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

Started

Jun 2023

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 to 75 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 or long-standing persistent AF proved on at least two 12-lead ECG recordings more than one week apart or \> 7-day EKG Holter recordings * Age ≥ 18 years at the time of study enrollment * Signed informed consent Exclusion Criteria: * Paroxysmal AF * Sinus rhythm on the 12-lead ECG on admission unless recent external electrical cardioversion was carried out within the last six months and the patient is treated by amiodarone * LA diameter \> 55 mm (measured in the parasternal long-axis view) * History of AF ablation in the past * History of cardiac surgery * Significant valvular defect * Age below 18 years * Pregnancy, breastfeeding * Any disease with a life expectancy \<1 year * Terminal renal failure * History of pacemaker or defibrillator implantation * Significant thyroid disease * Uncorrected congenital heart disease or valvular obstruction * Obstructive hypertrophic cardiomyopathy * Active myocarditis * Constrictive pericarditis * Untreated hypothyroidism or hyperthyroidism * Adrenal insufficiency * Active vasculitis due to collagen vascular disease * Presence on a heart transplant waiting list (UNOS category 1A or 1B or equivalent). Patients on a non-acute heart transplant waiting list (UNOS category 2 or 7 or equal) are eligible for inclusion in the study * Recipient of any major organ transplant (e.g., lung, liver, heart) * Patient who is undergoing or has undergone cytotoxic or cytostatic chemotherapy and radiation therapy for the treatment of malignancy within six months before randomization or clinical evidence of current malignancy, with the following exceptions: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if the localized disease is stable, with life expectancy \> 2.5 years in the opinion of the investigator) * HIV positivity with a survival expectancy of less than five years due to HIV * Chronic kidney disease with glomerular filtration rate \< 30 ml/min * Chronic dialysis treatment * Recent (within three months) self-reported history of alcoholism or illicit drug dependence * Any illness (e.g., psychiatric illness) or situation that, in the opinion of the investigator, could place the subject at significant risk, confound the results of the study, or significantly affect the subject's participation in the study * Unwillingness to participate.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Ceske Budejovice Hospital

    České Budějovice, 37001, Czechia

  • Institute for Clinical and Experimental Medicine

    Prague, 14037, Czechia

  • University Hospital

    Olomouc, 77900, Czechia

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