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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P210027 / PAS001 |
| Date Original Protocol Accepted |
07/20/2023
|
| Date Current Protocol Accepted |
|
| Study Name |
QDOT MICRO System PAS
|
| Device Name |
QDOT MICRO™ System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Observational, multi-center, non-randomized, post-market study. This is a
nested sub-study of the REAL AF Registry. Consecutive of symptomatic
drug refractory paroxysmal atrial fibrillation (PAF) patients from the
registry will be screened for enrollment to this sub-study per inclusion and
exclusion criteria.
Enrolled QDOT PAS subjects are defined as consented patients with
symptomatic PAF enrolled in the REAL AF registry treated with the QDOT
MICRO™ system (QDOT MICRO™ catheter and nGEN™ generator) in
conjunction with VISITAG SURPOINT™ Module. Subjects are required to
complete scheduled assessments within 12 months of the index procedure,
and additional two assessments at 24 and 36-month post procedure.
All subjects will undergo ablation procedures using the commercially
approved QDOT MICRO™ catheter and nGen™ generator using
QMODE+ and/or QMODE in conjunction with recommended VISITAG
SURPOINT™ tag index values. All consecutive patients who are
considered for an RF ablation procedure at study institutes would be
screened by the investigator or designated member of the research team for
sub-study eligibility. Eligible subjects will be consented for the participation
of this sub-study.
For the purpose of this sub-study, the first five (5) enrolled subjects will be
treated using QMODE with the recommend VISITAG SURPOINT™ tag
index values. This will also allow the operators to acclimate to the use of
QDOT MICRO™ catheter manipulation using conventional RF catheter
ablation.
The primary objective of this study is to evaluate the safety and
effectiveness of the QDOT MICRO™ System use in conjunction with
VISITAG SURPOINT™ Module in the treatment of symptomatic drug
refractory PAF.
|
| Study Population |
Study population will consist of patients in the REAL AF registry who have
symptomatic PAF and undergo ablation procedures using the QDOT
MICRO™ System with VISITAG SURPOINT™ Module
|
| Sample Size |
A total of 250 subjects will be enrolled, with at least 50% subjects from the
US sites. Each site will contribute to no more than 20% of the target
enrollment to allow for generalizable study results.
Number of subjects: 250
Assumptions for sample size estimation: performance goal (PG) of 12% for
the primary safety endpoint and a PG of 50% for the primary effectiveness endpoint, a sample size of 250 subjects will provide greater than 80% power of this study, controlling the overall type-I error rate at a one-sided 2.5% level under the null hypotheses
|
| Key Study Endpoints |
Safety Endpoints
Primary: The primary safety endpoint is the occurrence of early onset
Primary Adverse Events (PAE) within seven (7) days of an initial ablation
procedure using the QDOT MICRO™ System with VISITAG
SURPOINT™ Module
Secondary: please see study protocol
Effectiveness Endpoints
Primary: The primary effectiveness endpoint is the freedom from
documented (Symptomatic and asymptomatic) atrial arrhythmia (atrial
fibrillation (AF), atrial tachycardia (AT) or atrial flutter (AFL)) episodes
during the effectiveness evaluation period (Day 91-365)
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| Follow-up Visits and Length of Follow-up |
All subjects will be followed for 36 months. Follow up clinical data will be
collected at 10-12 weeks, 6, 12, 24, and 36 months post the ablation
procedure.
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