Atrial Fibrillation
Conditions
Brief 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.
Detailed 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. However, the catheters designed to deliver PFA differ to those used previously and may not provide the same information about efficacy, making it more difficult for the operator to ascertain if the lesions have durably isolated the pulmonary vein. This exploratory observational study will assess the utility of a software module designed to measure the local potential derived from the unipolar electrogram recorded at the electrode that has delivered the PFA. During the procedure, the study will collect data only and all analysis of the output of the PFAnalyzer software module will be made off-line once the procedure is complete. The operator will follow the hospital's standard of care during the procedure, and the software module will not be used to guide therapy, nor will there be any additional time added to the procedure. 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.
Interventions
DEVICEPulmonary vein isolation ablation
Electrical isolation of the pulmonary veins to treat atrial fibrillation
Sponsors
CathVision ApS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary vein isolation | intra-procedural | assess the agreement between pulmonary vein isolation status as determined by the operator using entrance block as well as exit block during PV pacing and as classified by the PFAnalyzer software based on unipolar local potential characteristics analyzed off-line, post procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical utility | intra-procedural | Assessment of the operators' subjective experience of clinical utility of the PFAnalyzer software measured through a 17-item questionnaire. |
| Identify a clinically meaningful threshold for residual potentials after PFA delivery. | intra-procedural | Identify a clinically meaningful threshold for residual potentials after PFA delivery by comparing the amplitude of manually expert labelled local potentials to none local potential signals. |
| Feasibility of guiding rotation | intra-procedural | Determine the feasibility of using PFAnalyzer to assist in optimizing rotation and placement of the catheter by measuring changes in local potential amplitude during rotation. |
Countries
United States
Contacts
CONTACTKarl P Firth, MSc
Outcome results
None listed