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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01401361 | Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System | PHASE3 | COMPLETED | 150 | — | — | Oct 1, 2011 | Sep 1, 2012 | Feb 15, 2019 | 20 | United States, Canada |
Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.
Primary efficacy or Acute success is defined as achievement of bidirectional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | Atrial Flutter RF Ablation treatment with the Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement. |
| Name | Type | Description |
|---|---|---|
| Treatment Arm | DEVICE | The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement . |
Inclusion Criteria: * A signed written Informed Consent * Presence of typical atrial flutter (cavo-tricuspid isthmus dependent) * If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then they need to be controlled on ...