NCT05922917Completed
Pulsed-field Ablation in Patients With Persistent Atrial Fibrillation
Pulmonary Vein Isolation Versus Complex Procedure Using Pulsed-field Ablation in Patients With Persistent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
Since a new method called pulsed-field ablation (PFA) has emerged, allowing significantly simpler, safer, and faster creation of ablative lesions in paroxysmal AF and PsAF (13), redefining the "optimal" ablation approach started to appear mandatory. Our project (The PIVCO study) aims to determine a more standardized procedure representing optimal ablation strategy for patients suffering from PsAF using PFA and multielectrode ablation catheters. The central hypothesis is that ablation of the posterior LA wall (PWI), together with mitral and cavotricuspid isthmus ablation added on top of PVI, will be associated with better effects in terms of rhythm control. Given the speed, safety, and ease of standardization of ablation using electroporation, a demonstration of the superiority of either approach could significantly impact the current standard of clinical care.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 518 (actual)
- First submitted
- 20 Jun 2023
- Start date
- Jun 2023
- Primary completion date
- Jul 2026
- Lead sponsor
- České Budějovice Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT05922917
What you commit to
- Study type: Interventional
- Participants enrolled: 518
- From Jun 2023 to the primary completion date, Jul 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- History of AF ablation in the past
- History of cardiac surgery
- 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
- 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)
- HIV positivity with a survival expectancy of less than five years due to HIV
- Chronic kidney disease with glomerular filtration rate \< 30 ml/min
- 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
Age
- Age below 18 years
Other
- 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)
- Significant valvular defect
- Pregnancy, breastfeeding
- Obstructive hypertrophic cardiomyopathy
- Active myocarditis
- Constrictive pericarditis
- Untreated hypothyroidism or hyperthyroidism
- Chronic dialysis treatment
- Unwillingness to participate.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| České Budějovice Hospital Coordinator of this site? Confirm its status | České Budějovice | Czechia | Unknown status |
| University Hospital Coordinator of this site? Confirm its status | Olomouc | Czechia | Unknown status |
| Institute for Clinical and Experimental Medicine Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.