Study:
Clinical Evaluation of Therapy™ Cool Flex™ Irrigated Ablation System for the Treatment of Typical Atrial Flutter
Rationale:
n/a
Purpose:
To demonstrate that ablation with the Therapy™ Cool Flex™ Irrigated Ablation System is
effective in the treatment of typical atrial flutter (cavo-tricuspid dependent) and that its
use does not result in an unacceptable risk of intra-procedural, serious cardiac adverse
events.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Typical Atrial Flutter |
Device: Therapy™ Cool Flex™ Irrigated Ablation System |
Phase 3 |
Verified by
St. Jude Medical
June, 2012
Sponsored by: St. Jude Medical
Information provided by: St. Jude Medical
ClinicalTrials.gov identifier: NCT01408485
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic / Cardiovascular Associates of Cleveland
Mayfield Heights, Ohio 44124
United States
Raul Weiss, MD., Principal Investigator