Atrial Fibrillation
Conditions
Brief summary
The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed using best practices, including optimized procedural techniques and anti-coagulation therapy.
Interventions
OTHERMagnetic Resonance Imaging (MRI)
MRI's will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at the Pre-Discharge will undergo an MRI at the 1 month follow-up visit.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is at least 18 years old * Subject has been diagnosed with atrial fibrillation (AF) * Subject is indicated for a pulmonary vein ablation using PVAC * Subject (or subject's legally authorized representative) is able and and willing to give informed consent.
Exclusion criteria
* Subject has permanent AF * Subject has a left atrial thrombus detected on TEE * Subject has had a prior left atrial ablation * Subject has a intracardiac thrombus * Subject is contraindicated for Warfarin (Coumadin) * Subject has a cardiac valve prosthesis * Subject has a significant congenital heart defect corrected or not including atrial septal defects or pulmonary vein abnormalities but not including minor PFO) * Subject has presence of any pulmonary vein stents * Subject has presence of any pre-existing pulmonary vein stenosis * Subject has had a cerebral ischemic event (strokes or transient ischemic attacks \[TIA\]) which occurred during the 6 month interval preceding the Consent Date * Subject is a woman known to be pregnant * Subject is unwilling or unable to comply fully with study procedures and follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI. | Within 1-3 days post ablation | An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Safety Events | 30 days | Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC. |
| Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject. | Day 1 (End of Procedure) | The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy. |
Countries
Belgium, Canada, Germany, Italy, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ablation | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Ablation |
|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 10 |
| Region of Enrollment Belgium | 13 participants |
| Region of Enrollment Canada | 12 participants |
| Region of Enrollment Germany | 12 participants |
| Region of Enrollment Italy | 11 participants |
| Region of Enrollment Netherlands | 12 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 60 |
| serious Total, serious adverse events | 1 / 60 |
Outcome results
Primary
New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.
An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact.
Time frame: Within 1-3 days post ablation
Population: All subject who underwent an ablation and post-procedure MRI.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ablation | New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI. | 1 participants |
Secondary
Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.
The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy.
Time frame: Day 1 (End of Procedure)
Population: All subjects who underwent ablation and post-procedure MRI.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ablation | Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject. | 60 participants |
Secondary
Acute Safety Events
Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.
Time frame: 30 days
Population: All subjects who underwent an ablation and post-procedure MRI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ablation | Acute Safety Events | 1 events |