Clinical Research Directory

P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation

Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia worldwide and is associated with substantial morbidity, mortality, and healthcare utilization. Catheter ablation, most commonly pulmonary vein isolation (PVI), is an established rhythm control strategy for AF4. Despite technological advances and the emergence of pulse field ablation (PFA), long-term AF recurrence after a first ablation procedure remains frequent, occurring in approximately 30-50% of patients5. Post-ablation follow-up strategies, including visit frequency, rhythm monitoring intensity, and Antiarrhythmic Drug management, vary widely across providers and institutions and are largely guided by subjective assessment rather than objective, science-based recurrence risk estimation6. In parallel, asymptomatic (silent) AF recurrence is exacerbated following ablation, limiting the reliability of symptom-driven follow-up7. FOLLOW-AF is a retrospective, observational cohort study designed to validate the FollowGenius algorithm and evaluate the diagnostic performance in predicting AF recurrence based on atrial remodeling and vein isolation. The cohort will be patients with paroxysmal or persistent AF who underwent PVI with the PFA modality.

Impact of Atrial Fibrillation Ablation on Sleep Parameters.

Assessment of Sleep Parameters Using Polygraphy in Patients with Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study: Afib Ablation and Hypopnea Index - The "AAHI" Study Principal Investigator: Dr. Paweł Basiukiewicz, MD, PhD Study Sponsor: Primula Clinics sp. z o.o. Żyrardowska 31, 05-825 Grodzisk Mazowiecki, Poland NIP (Tax ID): 529 183 03 11 Dear Sir/Madam, You have been invited to participate in a scientific study aimed at assessing sleep parameters in patients with atrial fibrillation undergoing rhythm-control therapy. Please read this document carefully before deciding whether to take part in the study. If you have any questions, please contact the principal investigator. Study Objective: To assess sleep parameters using polygraphy in the course of treatment of patients with paroxysmal atrial fibrillation qualified for pulmonary vein isolation. Study Procedures: The study involves four polygraphic sleep studies (two before and two after atrial fibrillation ablation), each conducted at least 7 days apart. The polygraphic studies will record the following parameters: pulse oximetry, heart rate, respiratory movements of the chest, and airflow through the anterior nares. The study includes only patients undergoing atrial fibrillation ablation for the first time. Risks and Benefits: The study is non-invasive and does not involve any direct health risks. Participation will not affect your treatment process, but it may provide valuable information about your health status. Voluntary Participation: Participation in the study is entirely voluntary. You may withdraw from the study at any time without providing a reason and without any impact on your ongoing medical treatment. Personal Data Protection (GDPR): In accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (General Data Protection Regulation - GDPR): The data controller is Primula Clinics sp. z o.o. Personal data will be processed solely for the purpose of conducting this study. Data will be stored no longer than required by law or necessary for the research purposes. You have the right to access your data, request its correction, deletion, restriction of processing, and to object to data processing. All data will be protected against unauthorized access.

Empiric Pulsed Field Pulmonary Vein Isolation During Atrial Tachycardia Ablation in Adults With Congenital Heart Disease

This is a prospective, single-arm intervention trial whereby we will test the safety and efficacy of performing pulmonary vein isolation (PVI) using pulsed field ablation (PFA) in adult patients with congenital heart disease (CHD) who are presenting for atrial tachycardia (AT) ablation.

Impact of Catheter Stability on the Outcomes With Very High Power Short Duration Ablation

Background: Atrial fibrillation (AF), the most common cardiac rhythm disorder can be treated with pulmonary vein isolation (PVI). One technique for PVI is point-by-point radiofrequency ablation. Very high power short duration ablation is one of the most advanced technologies for radiofrequency ablation. However, acute efficacy results with this technology vary in a wide range. Improvements in automated tagging modules, incorporating tracking of cardiac and respiratory motion and enhanced stability algorithms, may allow for a better assessment of lesion quality and location and may improve the so called first-pass isolation rate (an indicator for acute procedural efficacy). Objective: To assess the acute procedural outcomes of very high power short duration PVI with the new enhanced stability software. Methods: Investigator-initiated, prospective, single-arm study on one hundred symptomatic patients with paroxysmal AF will undergo PVI with the QDOT catheter using a power setting of 90W(QMODE+). The inter-tag distance will be 6 mm posteriorly and 4 mm anteriorly, and the enhanced stability algorithm will be used in all cases. After creating the isolation circle, the presence or absence of first-pass isolation will be assessed on each side by the presence of entrance block. Primary endpoint will be first-pass isolation rate. Secondary outcomes are as follows: procedure time, left atrial dwell time, RF time, number of RF tags, use of a steerable sheath, occurrence of serious adverse events. Hypothesis: Very high power short duration PVI using the new stability software results in a higher rate of first-pass isolation than previously published.

Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial

The purpose for this study is to determine whether left posterior wall isolation (PWI) in addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent atrial fibrillation (AF).