Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-24 @ 12:46 PM
NCT ID:
NCT01401361
Brief Summary:
To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter
* Does not result into unacceptable risk of intra-procedural composite serious adverse events and,
* Does not affect efficacy of the ablation procedure The study will also evaluate the
Detailed Description:
This will be a prospective, multi-center and non-randomized study. All enrolled patients who meet the eligibility criteria will receive ablation therapy for typical atrial flutter using the Contact Therapy™ Cool Path™ Cardiac Ablation System. Historical data from published (PMA P060019 Cool Path) , reported (IDE G090109 Cool Path Duo) and published literature on Atrial Flutter RF ablation studies is used to determine performance goals for primary study endpoints and derive the sample size. In addition, the following analyses will be performed in the study
1. Validation of ECI against conventional methods of assessing tip tissue contact and
2. Ancillary analysis to assess the relationship between the ECI and study outcomes. Subjects will undergo two follow up visits at day 10 and month 3 post procedure. The following assessments will be performed during these visits:
* ECG
* Query regarding adverse events since the last visit
* Assessment of anti-arrhythmic and anti-coagulation medication
* Query regarding recurrence or repeat ablation for typical atrial flutter
Study:
NCT01401361
Study Brief:
Protocol Section:
NCT01401361