atrial tachyarrhythmia quivering of the heart muscles of the atria
Conditions
Interventions
Eligible subjects who sign the study informed consent form will be randomized
into one of two study arms:
THERMOCOOL® Group: RF ablation to achieve PVI using the CARTO® 3 System,
THERMOCOOL® Cathet
Sponsors
Johnson & Johnson
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with PAF who have had two (2) symptomatic PAF episodes in the six (6) months prior to randomization, and who are selected for catheter ablation for the treatment of their AF. Additionally patients with recurrent AF with episodes up to 30 days with sinus rhythm maintained for more than one week following cardioversion and who require PVI only for the treatment of their AF. AT least one AF episode should be documented either on ECG, TTM, HM or telemetry strip.
Exclusion criteria
Exclusion criteria: 1. Longstanding persistent atrial fibrillation 2. Patients with a history of any atrial flutter requiring ablation in the right atrium during the study procedure 3. Patients in whom sinus rhythm was maintained for less than 1 week after electrical cardioversion 4. Previous ablation for AF 5. LA size > 55 mm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints supporting the objective are: Efficacy: Freedom from documented AF/AT recurrences without new AADs through 1 year follow-up Safety: Incidence of PV Stenosis (number of PVs with a reduction in diameter >= 50% at 6 months compared to baseline per CT or MRI) Efficiency: Total procedure time (minutes from introduction of first catheter to withdrawal of last catheter) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1. Acute procedural success (% of subjects with confirmed entrance block at the end of the ablation procedure) 2. Repeat ablation procedures for AF/AT recurrences through 1 year follow-up 3. Freedom from documented AF/AT recurrences without AAD(s) 4. Freedom from documented AF/AT recurrences with AAD(s) 5. Freedom from documented AF/AT recurrences after more than one ablation procedure 6. Freedom from documented AF recurrences without AADs 7. Freedom from documented AF recurrences with AAD(s) 8. Freedom from documented symptomatic AF/AT recurrences without AAD(s) 9. Freedom from documented symptomatic AF/AT recurrences with AAD(s) Safety: 1. Incidence of any procedure-related and/or device-related adverse events occurring during the study 2. Incidence of any catheter-related adverse events occurring during the study 3. Total Fluoroscopy exposure time from time point of first catheter inserted until last catheter removed (cumulative time including both fluoroscopy and cine-fluoroscopy times; minutes) 4. Total Fluoroscopy Dose-Area Product (DAP) (Gy.cm²) / Source Intensifier Distance 5. Incidence of any phrenic nerve paralysis 6. Incidence of any symptomatic Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA) Efficiency: • Number of mapping and ablation catheters used per subject Health Economics (HE) Outcomes: 1. Quality of Life (SF-36®) and Atrial Fibrillation Symptom Frequency and Severity Checklist assessment at 3, 6, and 12 months compared to baseline 2. Total procedure hospital visit and ablation procedure costs 3. Total number of initial or prolonged hospitalizations and unscheduled arrhythmia-related health care provider visits (including emergency department visits). | — |
Countries
Netherlands
Outcome results
None listed