New heart procedure aims to improve rhythm control in persistent AF patients
NCT ID NCT05922917
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Ceske Budejovice Hospital
České Budějovice, 37001, Czechia
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Institute for Clinical and Experimental Medicine
Prague, 14037, Czechia
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University Hospital
Olomouc, 77900, Czechia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Extra vein ablation tested to keep persistent AFib from returning
- Duel of ablation catheters: which wins for persistent AF?
- New ablation technique takes aim at stubborn heart rhythm problem
- Why do some hearts slow down after pulsed field ablation?
- Can a new drug stop long atrial fibrillation episodes?