VASCADE MVP 6–12F VVCS – AMBULATE Same-Day Discharge Studies
The objective of the registries was to collect procedural outcomes data when the Cardiva VASCADE MVP VVCS was used to seal femoral
venous access sites at the completion of catheter-based ablation procedures for atrial fibrillation with or without another arrhythmia,
performed through 6–12F inner diameter (maximum 15F OD) introducer sheaths in patients who were discharged on the same day as
the procedure (retrospective study) or who were eligible for same-day discharge (prospective studies). These studies add to the body
of knowledge for patient profiles subject to safe same-day discharge by focusing on patients who: 1) received VASCADE MVP VVCS for
closure involving multiple access sites in one or both limbs; and 2) were being treated for atrial fibrillation (AF) with or without another
arrhythmia. Ablation for atrial fibrillation, which is generally longer and/or more complex than for other arrhythmias, provides a
greater challenge for establishing the safety profile for same-day discharge than ablation for other arrhythmias.
Study
Retrospective
(AF All-Comers)
Procedures: Dec 2018-Feb
2020 | 497 Patients | 4 sites |
Standard of Care f/u
Prospective SDD#1
(Paroxysmal AF)
June 2020-Nov 2020 | 151
Patients | 8 sites | 15-day f/u
Prospective SDD#2
(Persistent AF)
Feb 2021-Jun 2021 | 203
Patients | 13 sites | 15-day
f/u
IFU 5686 AE, 2024-04
Table 12: Same-Day Discharge Studies Safety and Effectiveness Results
VASCADE MVP Success
(Freedom from Access Site
Population
Next Day
Discharged
99.8%
Same Day
(496/497)
Discharged
99.3%
Same Day
(137/138)
Discharged
90.7%
Same Day out
(137/151)
of ITT
99.3%
ITT
(150/151)
Discharged
100.0%
Same Day
(185/185)
Discharged
91.1%
Same Day out
(185/203)
of ITT
100.0%
ITT
(203/203)
Performance
Procedure Success
Complications)
Follow-Up
99.8%
99.6% (495/497)
(496/497)
99.3%
99.3% (137/138)
(137/138)
90.7%
90.7% (137/151)
(137/151)
99.3%
99.3% (150/151)
(150/151)
100.0%
99.5% (184/185)
(185/185)
91.1%
90.6% (184/203)
(185/203)
100.0%
99.0% (201/203)
(203/203)
Access Site Closure
(Freedom from
Related Complications
Next Day
Procedure-
Related
Major
Complications)
0.0%
(0/827)
0.0%
(0/193)
0.0%
(0/272)
Safety
Minor
0.1%
(1/827)
1.0%
(2/193)
0.7%
(2/272)
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