Paroxysmal Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation
Brief summary
To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types. 1. visually guided ablation (VGA) using the EAS-AC and 2. radiofrequency ablation
Detailed description
The goal of the study was to compare two interventions, visually-guided endoscopic ablation to standard-of-care radiofrequency (RF) ablation. The study was terminated early by the Sponsor for business reasons before any participants were randomized or treated with RF ablation.
Interventions
DEVICEEndoscopically guided PVI Ablation
Endoscopically Guided Ablation using the EAS-AC
DEVICERF PVI Ablation
Radiofrequency ablation
Sponsors
CardioFocus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic, Paroxysmal Atrial Fibrillation (AF) * 18 to 75 Years of age * Generally good overall health as determined by multiple criteria * Willing to participate in a study * Others
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation | 3 Months | Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs). |
Countries
Czechia, Italy
Participant flow
Pre-assignment details
The Sponsor stopped the study for business reasons before any participants were enrolled in the RF arm.
Participants by arm
| Arm | Count |
|---|---|
| Visually Guided Ablation Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not eligible | 0 | 2 |
Baseline characteristics
| Characteristic | Visually Guided Ablation |
|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 8 |
| Region of Enrollment Czech Republic | 16 participants |
| Region of Enrollment Italy | 5 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 2 / 19 |
Outcome results
Primary
Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation
Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).
Time frame: 3 Months
Population: Of the 21 enrolled participants, 19 were treated participants and 17 of the 19 came back for the 3 month PV remapping and were thus evaluable for effectiveness. This resulted in 46/59 (78%) pulmonary veins being assessed for chronic isolation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Number of Chronically Isolated Pulmonary Veins | Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation | 46 isolated pulmonary veins |