Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Therapy Cool Flex Ablation Catheter · 1 trial · 1 indication
* 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...
The Therapy Cool Flex Ablation Catheter is an investigational device being studied for the treatment of paroxysmal atrial fibrillation, a type of irregular heartbeat that comes and goes. It is designed to ablate, or destroy, heart tissue that causes abnormal electrical signals. The device is currently in clinical development and is not yet approved.
The Therapy Cool Flex Ablation Catheter is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker ABT. Abbott is conducting clinical research to evaluate the safety and effectiveness of this ablation catheter for treating paroxysmal atrial fibrillation.
The Therapy Cool Flex Ablation Catheter is in Phase 2 clinical development. It is an investigational device, meaning it has not been approved by regulatory authorities. A Phase 2 study has been completed to assess its use in patients with paroxysmal atrial fibrillation, but further research may be needed.
The Therapy Cool Flex Ablation Catheter has one completed clinical trial, registered as NCT01185613. This Phase 2 study, titled 'Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation,' enrolled 50 participants across Australia, France, Germany, Italy, Portugal, and the United Kingdom.
The Therapy Cool Flex Ablation Catheter is also known as the Therapy Cool Flex catheter. The clinical trial NCT01185613 refers to it as the Therapy™ Cool Flex Ablation Catheter. Both names refer to the same investigational device being developed by Abbott Laboratories for treating paroxysmal atrial fibrillation.