CARDIVA VASCADE MVP Manuel D'utilisation page 5

The safety and efficacy of the VASCADE MVP was evaluated in the following clinical studies to support the approved indications
for use: the AMBULATE Trial and the AMBULATE Same Day Discharge Study series. The design and results of each study are
provided below.
Objective Evaluate safety and effectiveness of VASCADE 6–12F VVCS to seal multiple femoral venous access sites and
reduce times to haemostasis and ambulation vs. Manual Compression (MC) after catheter-based procedures
(interventional electrophysiology procedures for the ablation of cardiac arrhythmias, which included atrial
fibrillation, atrial flutter, atrial fibrillation-flutter, supraventricular tachycardia and ventricular tachycardia)
performed through 6–12F introducer sheaths.
Design* Prospective, randomised (1:1), controlled, multi-centre clinical trial conducted at 13 sites in the USA.
Randomisation was stratified to account for patients with different numbers of access sites, i.e. 3 access
sites/patient and 4 access sites/patient, in a 1:1 treatment device to control arm ratio to ensure treatment
and control arms had the same average number of access sites/patient. All patients were scheduled to return
for follow-up examinations at 30 ± 7 days post-procedure. Post-procedure, patients were evaluated for any
major or minor complications or adverse events, including bleeding as well as neurological and other
potential device- or procedure-related adverse events.
• ≥ 18 years of age.
• Able and willing to sign an Informed Consent Form.
• Eligible candidates for an elective, non-emergency catheter-based procedure via the common femoral
Inclusion
vein using a 6F to 12F introducer sheath who were also eligible for post-procedure manual compression.
Criteria
• Minimum of 3 and maximum of 4 femoral venous access sites.
• Minimum of 2 access sites per leg.
• Able and willing to complete a 30-day ± 7 days follow-up evaluation.
• Active systemic or cutaneous infection or inflammation in vicinity of the groin.
• Any pre-existing immunodeficiency disorder.
• Chronic use of high dose systemic steroids.
• History of bleeding diathesis, coagulation defect or hypercoagulability.
• Platelet count < 100,000 cells/mm
• Severe comorbidities with life expectancy of less than 12 months in the opinion of the site investigator.
• History of femoral arteriotomy or venotomy within the last 10 days.
Exclusion
• History of vascular complications or residual haematoma.
Criteria
• Treatment with an intravascular closure device within the last 30 days or scheduled for femoral venous
or arterial access within the next 30 days.
• History of DVT, pulmonary embolism, thrombophlebitis, significant anaemia or renal insufficiency.
• Extreme morbid obesity (BMI > 45 kg/m
• Unable to routinely walk at least 6.1 metres without assistance.
• Use of low molecular-weight heparin (LMWH) within 8 hours before or after the procedure;
• Concomitant procedures or conditions that would interfere with an ambulation attempt at 2-3 hours
post-procedure.
• Any attempt at femoral arterial access.
• Procedural complications that would interfere with normal time to recovery, ambulation or discharge.
Intra-Operative
• Difficulty with needle puncture or insertion of the introducer sheath.
Exclusion
• Sheath placement cephalad to lower half of the femoral head or the inferior epigastric vein origin from
Criteria
the external iliac vein.
• Obvious intraprocedural bleeding or thrombotic complications.
• Any use of a sheath < 6 or > 12F inner diameter or tissue tract < 2.5 cm deep.
*49 patients were included in a sub-study in which they underwent ultrasound examinations at the 30 ± 7-day follow-up visit.
**202 of 204 randomised subjects (99%) completed the 30-day follow-up visit, with 175 patients (85.8%) completing the 30-day (± 7 days) follow-up visit per
protocol. Two (2) subjects did not complete the study (i.e., did not complete the 30-day visit or call).
IFU 5686 AE, 2024-04
Clinical Studies
VASCADE MVP 6–12F VVCS – AMBULATE Clinical Trial
Study Design and Baseline
Table 1: AMBULATE Study Design
AMBULATE Trial
3 .
) or underweight (BMI < 20 kg/m
2
).
2
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