Study CZ-060620231904
Study Name
Pulmonary vein isolation versus complex procedure using pulsed-field ablation in patients with persistent atrial fibrillation (the PIVCO study)
Clinical Trial Registry Identifier
CZ-060620231904
Study First Received
06.06.2023 19:00
Sponsor
TBD
Principal Investigator
Prof. Alan Bulava, MD, PhD (Ceske Budejovice Hospital), Coinvestigators: Tomas Skala (University Hospital Olomouc, Czech Republic), Jiri Hanis (Ceske Budejovice Hospital)
Information provided by
Alan Bulava
Purpose
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.
Primary endpoints
(1) The primary endpoint will be a recurrence of AF (or atrial tachycardia, AT) lasting >30 seconds as assessed using repeated 7-day ECG Holter monitoring in patients without anti-arrhythmic drugs (AADs) during the entire post-blanking follow-up, i.e., starting three months after the index procedure. All patients should complete a 12-month follow-up period.
Secondary endpoints
Secondary endpoints (1) The first recurrence of on-AADs AF/AT lasting >6 minutes during the post-blanking follow-up period (i.e., disregarding all off-AAD episodes). (2) Number of hospitalizations and emergency out-patient visits related to AF/AT recurrence, worsening of heart failure, or other cardiovascular diseases. (3) Number of electrical cardioversions. (4) Proportion of patients on AADs at the end of follow-up. (5) PFA-related complications. (6) Assessment of the quality of life using standardized instruments (AFEQT, EQ5D). (7) Feasibility of achieving a complete block of the mitral isthmus and PWI using PFA (8) Proportion of patients with delayed conduction into LAA after mitral line (9) Number of patients that underwent repeated ablations during follow-up
Eligibility
Patients scheduled to catheter ablation of PsAF will be screened in two complex cardiovascular centers in the Czech Republic: Cardiac Centre, Ceske Budejovice Hospital and Teaching Hospital Olomouc. Patients with documented non-paroxysmal AF will be recruited during the clinical review before the ablation procedure. Their demographic data (i.e. age, gender, type of planned surgery) will be recorded in the screening section of the CRF. The reason for non-eligibility will be directly specified in inclusion/exclusion CRF section. Written informed consent with the study will be obtained from all eligible patients prior to the ablation. All participating centers will have an appointed local investigator who will be responsible for appropriate enrolment of patients, their follow up, and data management. The regulations regarding medical confidentiality and data protection will be fulfilled. Inclusion criteria Patients with non-paroxysmal AF need to meet all criteria as follows: 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 were as follows: 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. Statistical methods. Continuous variables will be expressed as arithmetic means, standard deviations, and corresponding 95% confidence intervals (CI) or median and interquartile range. Groups (subgroups) will be compared using the 2-tailed t-test for independent samples or the MannWhitney U test for clearly non-normally distributed data. The chi-square test or Fishers exact test, as appropriate, will be used for categorical data. The influence of mutually independent risk factors will be quantified based on the hazard ratio (HR) and its 95% CI. Both univariate and multivariate-adjusted HRs will be estimated using the Cox proportional hazard models with an adopted forward stepwise algorithm. Outcome measures will be analyzed based on the intention-to-treat protocol. P values < 0.05 will be considered statistically significant. Analyses will be performed using the R software (Team, 2022). Based on published results using radiofrequency energy and electroporation (14, 15), the off-AADs arrhythmia recurrence rate (primary treatment endpoint) after the PVI vs. PVI+ strategies can be estimated at 55% vs. 75%, respectively. To ensure 90% power for the study, which would be needed to detect the difference between both arms at the 5% significance level (two-sided Z-test), 256 patients must be analyzed in each arm of the trial. Considering a dropout rate of 15%, approximately 300 patients will need to be enrolled in the trial.
Contacts and Locations
Contact: Prof. Alan Bulava, MD, PhD, Ceske Budejovice Hospital, Czech Republic, tel. +420 387 87 4389, email: alanbulava@seznam.cz
More Information
Target sample size: 300 Countries of recruitment: Czech Republic
Keywords
Key words: atrial fibrillation, catheter ablation, pulsed field, electroporation, randomized controlled clinical trial
Status
Ongoing - recruiting
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