Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01185613 | Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation | PHASE2 | COMPLETED | 50 | — | — | Jun 1, 2010 | Sep 1, 2011 | Feb 4, 2019 | 6 | Australia, France +4 |
* Ablation parameters (such as average power delivered , average tip temperature , average impedance ) * Lesion locations (such as PVI, Septal line, Mitral isthmus, CTI or any other lesion location) * Mapping techniques (Mapping system and catheter) * RF application time ( Calculated from the total number of RF application and duration of each RF application) * Ablation procedure time (Time from the first to the last RF application) * Total irrigation fluid administered during ablation procedure * Fluoroscopy time
* Recurrence of AF through six months post last RF ablation procedure using Cool Flex catheter. A 24 hour Holter will be provided to the patients for six month follow-up visit in order to monitor AF episodes. An AF episode will be considered a recurrence only if it lasts for 30 seconds or more. * AF recurrences during the blanking period (defined below) will not be reported.
All serious adverse events through six month follow-up
| Arm | Type | Description |
|---|---|---|
| Therapy™ Cool Flex Ablation Catheter | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Therapy™ Cool Flex Ablation Catheter | DEVICE | The device under evaluation is the 4mm Therapy™ Cool Flex Ablation Catheter. The Therapy™ Cool Flex catheter is a flexible tip, insulated, 7F catheter constructed of thermoplastic elastomer material and noble metal electrodes. The following CE Mark devices will be used in conjunction with the Therapy™ Cool Flex Ablation Catheter * IBI-1500T11 Cardiac Ablation Generator (RF ablation generator) with software version 3.0 or higher. * Cool Point™ Irrigation Pump * Cool Point™ Tubing set * Data Logger |
Inclusion Criteria: * A signed written Informed Consent form * 18 years of age or older * Agrees to comply with follow-up visits and evaluation * Candidate for catheter ablation for the treatment of paroxysmal atrial fibrillation as per the hospital standard of care. Exclusion Criteria: * Persist...