|
|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P200002 / PAS001 |
| Date Original Protocol Accepted |
04/28/2021
|
| Date Current Protocol Accepted |
12/11/2023
|
| Study Name |
CONVERGE Post-Approval Study
|
| Device Name |
EPi-Sense Guided Coagulation System
|
| 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) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense and Epi-Sense ST Guided Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.
The study is a prospective single arm study with safety and effectiveness compared to performance goals which are based upon published literature.
|
| Study Population |
Patients at sites participating in Medtronic’s Cryoablation Registry, who are 18 years of age or older and are recommended for ablation with the Artic Front Cardiac Cryoablation Catheter System for treatment of persistent atrial fibrillation.
|
| Sample Size |
325 subjects will be enrolled. This sample size will have 90% power for the Primary effectiveness and 80% power for the primary safety endpoints
|
| Key Study Endpoints |
The primary effectiveness endpoint is defined as freedom from AF/AT/AFL absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-month blanking period through the 12-months post procedure follow-up visit
The Primary Safety Endpoint is the severe adverse event rate through 12-months post-procedure.
The primary safety endpoint for the study includes major adverse events (MAEs):
The incidence of MAEs through 30-days post Hybrid Convergent procedure
The incidence of MAEs related to Hybrid Convergent procedure
The incidence of MAEs related to Hybrid Convergent devices
Additional endpoints: Clinically significant pericardial effusion;
Device and procedure related serious adverse events through 12-months post-procedure;
Change in AF symptoms from baseline to 12-, 18-, 24-, and 36-months post-procedure;
Freedom from AF/AT/AFL >30 seconds duration absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-month blanking period through the 12-months post procedure follow-up visit. Evaluated based on the first 24 hours of the 7-days Holter monitoring and symptom-driven event monitoring;
Freedom from any AF/AFL/AT >30 seconds duration without a Class I/III AAD prescribed for AF following the 3-month blanking period through 12- 18-, 24- and 36- months post-procedure;
Freedom from any AF/AFL/AT >30 seconds duration with or without an AAD prescribed for AF following the 3-month blanking period through 12-, 18-, 24- and 36- months post -procedure;
Residual AF burden / reduction in overall AF burden at 12-, 18-, 24- and 36-months post procedure when compared to baseline; and
Change in AF-specific Quality of Life (QoL) score(s) at 12-, 18-, 24- and 36- months post-index procedure when compared to baseline score.
|
| Follow-up Visits and Length of Follow-up |
All treated subjects will be followed for a total of 36-months.
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
Insufficient information available for any safety conclusions
Effectiveness Results
Insufficient information available for any effectiveness conclusions
|
| Actual Number of Patients Enrolled |
11
|
| Actual Number of Sites Enrolled |
9
|
| Patient Follow-up Rate |
No subjects lost to follow-up; three reported deviations of visits completed outside of time window
|
