A Prospective Observational Study Evaluating the Incidence of Silent Cerebral Lesions and Procedural Safety Following Atrial Fibrillation Ablation Using the VARIPULSE™ Pulsed Field Ablation System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Study Type: Observational Study Goal: The goal of this study is to evaluate the incidence and burden of silent cerebral lesions (SCLs) detected on brain magnetic resonance imaging (MRI) after pulsed field ablation (PFA) for atrial fibrillation (AF). PFA is a new non-thermal ablation technique that selectively targets cardiac tissue while minimizing damage to surrounding structures. The study focuses on adult patients with paroxysmal or persistent AF who undergo left-atrial ablation using the VARIPULSE PFA system.
Detailed description
Main Questions the Study Aims to Answer:
What percentage of patients develop silent cerebral lesions after PFA using the VARIPULSE system?
What are the lesion characteristics (number, size, and location) and total lesion burden on MRI?
Are there any early neurological or cognitive changes related to these MRI findings?
Comparison:
This is an observational, single-arm study with no active control group. However, the findings will be compared with historical data from previous studies of thermal ablation (radiofrequency and cryoballoon) to explore potential differences in neurological safety.
Participant Activities:
Participants in this study will:
Undergo brain MRI (DWI and FLAIR sequences) within 1-3 days after PFA to detect any silent cerebral lesions.
Complete neurological and cognitive assessments (for example, tests of memory, language, and attention) to identify subtle functional changes.
Receive routine clinical follow-up for AF management according to institutional standard of care.
Background:
Silent cerebral lesions are small ischemic brain injuries seen on MRI that cause no immediate symptoms but have been linked to later cognitive decline and increased risk of clinical stroke. They are known to occur in 10-40 % of patients after conventional AF ablation using radiofrequency or cryoballoon energy. Because PFA employs electrical pulses rather than heat, its effects on cerebral safety may differ. The VARIPULSE system integrates a variable-loop, multipolar PFA catheter with a three-dimensional electro-anatomical mapping system to improve procedural precision and reduce risk.
Significance:
As PFA use expands in clinical practice, understanding its neurological safety is crucial. This study will provide quantitative MRI data and standardized neurological evaluations to define the cerebral safety profile of PFA. The results are expected to inform procedural optimization and help establish evidence-based strategies for safer AF ablation.
Primary outcome measures
- Incidence of silent cerebral lesions (SCLs) [Time frame: From enrollment to the end of treatment at 3 months]
Secondary outcome measures (5)
- Number and total volume (mm³) of silent cerebral lesions (SCLs) in patients with positive SCL findings after the procedure. [Time frame: From enrollment to the end of treatment at 3 months]
- Neurological complications [Time frame: From enrollment to the end of treatment at 3 months]
- Cognitive function [Time frame: From enrollment to the end of treatment at 3 months]
- Quality of Life (QoL) [Time frame: From enrollment to the end of treatment at 3 months]
- General health status [Time frame: From enrollment to the end of treatment at 3 months]
Eligibility criteria
Inclusion criteria
1\) Patients undergoing atrial fibrillation ablation using the Varipulse™ catheter
Exclusion criteria
- Individuals under 19 years of age
- Patients who undergo concomitant radiofrequency ablation of the left atrium during the procedure
- Patients with a history of stroke or transient ischemic attack (TIA)
- Patients who have previously undergone ablation or surgery for atrial fibrillation
- Patients with intracardiac thrombus or embolic events within the past 90 days
- Patients who have experienced cardiac surgery or acute coronary syndrome within the past 90 days
- Patients with contraindications to oral anticoagulant therapy, or those who require temporary discontinuation of anticoagulation due to procedural complications (e.g., cardiac tamponade)
- Patients with a left ventricular ejection fraction (LVEF) of less than 35%
- Women who are currently pregnant or planning to become pregnant during the study period
- Patients with a life expectancy of less than one year
- Patients at increased risk during MRI scanning (e.g., those with pacemakers or other metallic implants affected by MRI, or those with severe claustrophobia)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
South Korea · 1 center
- Seoul National Universtiy Hospital, Seoul — Seoul
Identifiers
NCT: NCT07363278 · VARIACE study