|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P020045 / PAS001 |
Date Original Protocol Accepted |
04/17/2003
|
Date Current Protocol Accepted |
04/17/2003
|
Study Name |
CryoFACTS
|
Device Name |
7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
Observational single arm, non-randomized study and literature review
|
Study Population |
Adults referred for ablation of AVNRT.
|
Sample Size |
75 subjects from 10-15 sites Subjects from medical literature
|
Key Study Endpoints |
Device or procedure-related A-V block that persists through discharge;
Device or procedure-related A-V block that persists through discharge and requires the insertion of a permanent pacemaker;
Acute procedural success, defined as absence of recurrence and non- inducibility of the targeted antrioventricular nodal reentrant tachycardia.
|
Follow-up Visits and Length of Follow-up |
3 months Discharge and three months.
|
Interim or Final Data Summary |
Interim Results |
Of the 54 participants, none have had device or procedure related AV block persistent through discharge from the hospital.
|
Actual Number of Patients Enrolled |
75 in study 705 from literature
|
Actual Number of Sites Enrolled |
4
|
Patient Follow-up Rate |
100%
|
Final Safety Findings |
Of the 75 participants, none have had AV block persistent through discharge from the hospital (95% CI = 0-4.8%). There were no subject deaths.
Study and literature combined - Permanent AV block: 0% (95% CI=0% - 0.5%)
|
Final Effect Findings |
Acute procedural success has been reported in 71 of the 74 participants (95.9%) for whom ablation was performed.
Study and literature combined - Acute procedural success: 93.5% (95% CI=91.5% - 95.1%)
|
Study Strengths & Weaknesses |
Both safety and effectiveness objectives were met by a good margin. Literature review suffers from potential lack of representativeness.
|
Recommendations for Labeling Changes |
None
|