AMBULATE study of VASCADE MVP system meets primary endpoint

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The VASCADE MVP (Cardiva Medical), a vascular closure system designed specifically for multi-access venous closure following electrophysiology procedures such as arrhythmia ablation, met its endpoints compared to manual compression in a pivotal clinical study. The AMBULATE study is the first randomised pivotal trial of vessel closure conducted exclusively by electrophysiology physicians.

“The feedback from our patients and staff was extremely positive with VASCADE MVP during the study,“ said Andrea Natale, executive medical director, Texas Cardiac Arrhythmia Institute, USA. “Patients with previous procedures noticed a significant improvement in their level of comfort due to the much shorter bed rest time, and the time saved overall enabled us to implement a new more efficient workflow in the hospital. Additionally, there was a substantial decrease in the use of post-procedural pain medications in patients receiving the VASCADE device. This type of innovation will be particularly important as demand for these procedures continues to grow.”

The results were presented in the Late-Breaking Presentations section of the American Heart Association’s Scientific Sessions.

Study design

The AMBULATE study was a randomised, controlled clinical trial that enrolled 204 patients who underwent arrhythmia ablation procedures by 28 physicians at 13 sites across the USA. All patients had multiple (three or four) mid-bore (6–12F inner diameter sheath) femoral venous access sites, and were randomised into one of two groups. The treatment group had all sites closed with the VASCADE MVP System, while the control group had all sites closed using manual compression, which is the current standard of care. Patients were enrolled with both radiofrequency and cryo energy sources used in their procedures. Principal investigators include Andrea Natale; Mintu Turakhia, associate professor, Stanford University School of Medicine; and Steve Compton, Alaska Heart and Vascular Institute.

Compared to manual compression, the VASCADE MVP System met all primary and key secondary endpoints, including:

· Time to ambulation (primary endpoint, a measure of how quickly patients are able to get up on their feet and walk following vessel closure). The VASCADE MVP arm showed a median reduction of 3.9 hours (2.2 hours vs. 6.1 hours, p-value <0.0001).
· Total post-procedure time. The VASCADE MVP arm showed a mean reduction of 3.7 hours in the total time from completion of the ablation procedure to the patient walking. This was inclusive of the time to achieve vessel closure (3.1 hours vs. 6.8 hours, p-value <0.0001).
· Time to discharge eligibility. VASCADE MVP reduced the mean time for patients to be deemed eligible for discharge by 3.4 hours (3.1 hours vs. 6.5 hours, p-value <0.0001).
· Patient satisfaction. The patient-reported level of satisfaction with the duration of bed rest was 63% higher in the VASCADE MVP arm (8.3 score out of 10 vs. 5.1 out of 10, p-value <0.0001).
· Opioid pain medications (ad hoc analysis). Fifty eight per cent fewer patients in the VASCADE MVP arm used opioid-class pain medications following their procedure (15% of patients vs. 36% of patients, p-value 0.001).

The AMBULATE Series of Clinical Studies

· AMBULATE IMPACT Study – a recently completed study that examines today’s workflow following ablation procedures with a focus on improving hospital economics through early patient ambulation and improved workflow. Results from the AMBULATE IMPACT study will be published in 2019.
· AMBULATE CAP Study – a continued access protocol study designed to evaluate the safety of VASCADE MVP with earlier hospital discharge, elimination of urinary catheters, and elimination of protamine drug use in the setting of electrophysiology procedures. The AMBULATE CAP protocol is currently being conducted with approval of the US Food and Drug Administration (FDA).

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