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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P200002 / PAS001 |
| Date Original Protocol Accepted |
04/28/2021
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| Date Current Protocol Accepted |
10/07/2025
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| Study Name |
CONVERGE Post-Approval Study
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| Device Name |
EPi-Sense Guided Coagulation System
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| Clinical Trial Number(s) |
NCT01984346
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| 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.
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| Study Population |
Patients diagnosed with long-standing persistent AF defined in accordance with the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement.
Long-standing Persistent: Continuous AF of greater than 12-months duration.
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| Sample Size |
52 Subjects were enrolled at 23 sites including sites in US, UK and EU
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| 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.
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| Follow-up Visits and Length of Follow-up |
All treated subjects will be followed for a total of 36-months.
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| Interim or Final Data Summary |
| Interim Results |
Safety Results
As of March 20, 2026, 63 adverse events were reported in 29 treated subjects, including 26 SAEs in 16 subjects, 5 primary safety endpoint events, and no
deaths or UADEs.
Effectiveness Results
The document states that no data analysis has been performed to date (Section C.16 – Interpretation of Study Results). Effectiveness findings are therefore
not yet available. Final analyses will be conducted following completion of 36-month follow-up for all treated subjects, with a Clinical Study Report
subsequently submitted to FDA.
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| Actual Number of Patients Enrolled |
53
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| Actual Number of Sites Enrolled |
11
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| Patient Follow-up Rate |
Subject Progress by Visit
Visit Timepoint Number of Subjects
Visit 1 Baseline 53
Visit 2 Pre-Procedure 43
Visit 3 Procedure 43
Visit 4 7-Day 43
Visit 5 14-Day42
Visit 6 21-Day43
Visit 7 28-Day43
Visit 7.1 (Staged) Pre-Procedure 19
Visit 7.2 (Staged) Endocardial Procedure
19
Visit 7.3 (Staged) 7-Day Post Endocardial
19
Visit 8 1-Month 39
Visit 9 3-Months 38
Visit 10 6-Months 38
Visit 11 12-Months 23
Visit 12 18-Months 16
Visit 13 24-Months 10
Visit 14 36-Months 5
Early Termination — 17
Study Complete — 5
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