|
General |
Study Status |
Terminated |
Application Number / Requirement Number |
P050024 / PAS001 |
Date Original Protocol Accepted |
03/13/2008
|
Date Current Protocol Accepted |
03/13/2008
|
Study Name |
Cryocor Ablation PAS
|
Device Name |
CRYOCOR CRYOABLATION SYSTEM
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
Sponsor Registry
|
Comparison Group |
Concurrent Control
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
This is a two armed observational study. The sponsor states sequential subjects who do not meet the exclusion criteria are enrolled into the study from a registry of patients treated for right atrial flutter with the CryoCor Cardiac Cryoablation System (study subjects) or approved radiofrequency catheter (controls). Enrollment will be sequential for eligible subjects, except that when the ratio of patients in the control arm to patients in the study arm exceeds 4:1, enrollment in the control arm will temporarily cease until an equal number of subjects have been enrolled in the study arm.
|
Study Population |
Sequential subjects who do not meet the exclusion criteria are enrolled into the study from a registry of patients treated for right atrial flutter with the CryoCor Cardiac Cryoablation System (study subjects) or approved radiofrequency catheter (controls). Enrollment will be sequential for eligible subjects, except that when the ratio of patients in the control arm to patients in the study arm exceeds 4:1, enrollment in the control arm will temporarily cease until an equal number of subjects have been enrolled in the study arm.
|
Sample Size |
325 pattients from 30 sites.
|
Key Study Endpoints |
Procedure-related adverse events within 7 days of procedure; 12 month atrial flutter recurrence free rate.
|
Follow-up Visits and Length of Follow-up |
A clinical assessment for adverse events is scheduled at 7 days post-procedure. After that, patients are contacted by phone at 3, 6, and 12 months post-procedure to assess the patient for adverse events and recurrence of atrial flutter.
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