|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030031 / PAS001 |
| Date Original Protocol Accepted |
12/19/2005
|
| Date Current Protocol Accepted |
12/19/2005
|
| Study Name |
Navastar Thermocool
|
| Device Name |
BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This was a multi-center, observational, one-armed prospective cohort study of patietns with atrial flutter treated with the device.
|
| Study Population |
Subjects from several different centers with symptomatic typical atrial flutter who meet the inclusion/exclusion criteria. It is indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording), and when used with the Stockert 70 generator, for the treatment of Type I atrial flutter in patients age 18 or older.
|
| Sample Size |
291 subjects at 21 sites
|
| Key Study Endpoints |
The primary effectiveness endpoint was confirmation of complete bidirectional conduction block across the subeustachian isthmus at a minimum of 30 minutes following the last radio frequency application. Success was considered to be 88% effectiveness, with a one-sided 95% lower confidence bound of 80%. The primary safety endpoint was the percentage of subjects experiencing cardiovascular specific adverse events within seven days of the ablation procedure. Success was considered to be a CSAE no greater than 2.7%, with one-sided 95% confidence level no greater than 7%.
|
| Follow-up Visits and Length of Follow-up |
One month, one year, and annually thereafter for a total follow-up of 5 years.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
291 patients
|
| Actual Number of Sites Enrolled |
21 sites
|
| Patient Follow-up Rate |
100%
|
| Final Safety Findings |
Cardiac specific adverse events occurred in 4 of 267 subjects (two complete heart blocks, one pulmonary embolus, one myocardial infarction) in the safety cohort (1.5%). The upper one-side 95% confidence bound was 3.6%. All cardiac specific adverse events occurred in the primary group, in which the rate was 1.7% (upper 95% bound of 3.8%). Only one of the 4 was determined to be related to the device or the procedure. All 4 resolved. There were no deaths or unanticipated adverse events.
|
| Study Strengths & Weaknesses |
The strength of the study was the excellent follow-up and prospective cohort study design.
|
| Recommendations for Labeling Changes |
None
|
