Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation. REFINE-PFA
CathVision ApS
Summary
The study is a prospective, exploratory observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the FaraPulse PFA system. The cohort will be patients with paroxysmal or persistent atrial fibrillation (AF) who undergo PVI using this system.
Description
Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with a five-fold increase in stroke. Pulmonary vein isolation (PVI) has become accepted treatment for AF. Historically, this has been achieved using thermal energy. However, more recently a new energy source known as pulsed field ablation (PFA) has been introduced. As PFA is tissue selective, it preserves the function of nearby structures such as the esophagus and phrenic nerve making it safer to use. As PFA is delivered in short bursts of high energy, it is also more efficient and leads to shorter procedures. How…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Eligible subjects will meet all of the following inclusion criteria: 1. Subjects undergoing first time pulmonary vein isolation indicated by investigator for the treatment of atrial fibrillation. 2. Male or non-pregnant female aged ≥21 years. 3. Able and willing to provide written informed consent prior to any clinical investigation related procedure. 4. Subjects in sinus rhythm at the time of the PFA application. Exclusion Criteria: Eligible subjects will not meet any of the following exclusion criteria: 1. Pregnant or nursing subjects. 2. Current participation in ano…
Interventions
- DevicePulmonary vein isolation ablation
Electrical isolation of the pulmonary veins to treat atrial fibrillation
Locations (2)
- Trinity Health Ann Arbor HospitalYpsilanti, Michigan
- The Valley HospitalParamus, New Jersey