VASC-AF Study: Vascular Closure vs Manual Compression

Condition(s) studied

Investigational drug(s) / intervention(s)

Vacular closure: Vascular closure device

Study summary

The aim of this study is to reduce the time to ambulation after PVI by a vascular closure device as compared to manual compression and a figure-of-8 suture only. Safety, efficacy and feasibility of the VASCADE MVP device should be proven, too. The definition of endpoints will be trained in all participating study sites to preserve consistency.

The primary efficacy endpoint is time to ambulation after sheath removal. Time to ambulation is defined as the elapsed time between removal of the final closure device or removal of the final sheath and when the patient can stand and walk 20 ft without evidence of venous re-bleeding from the femoral access site.

The primary safety endpoint is the incidence of major periprocedural adverse events defined as adverse events until hospital discharge requiring medical intervention. Vascular access complications requiring solely the application of a pressure bandage will be classified as minor adverse event.

After fulfillment of all inclusion and exclusion criteria (see 5.1. and 5.2.) and written informed consent, patients will be randomized to either group 1 or group 2 in a 1:1 ratio:

Group 1:

50 patients treated with VASCADE MVP to achieve hemostasis

Group 2:

50 patients treated with manual compression and one figure of eight suture Clinical follow-up will be evaluated at hospital discharge, as well as at day 30 by a phone call using a standardized questionnaire. This will be performed as part of clinical routine. The follow-up period starts following randomization at day 1 after PVI.

An overview on the assessment of the study endpoints with the corresponding time point is displayed in the following table. During in hospital stay, need for pain medication due to issues of the femoral access site will be documented separately

Eligibility

Primary outcome measure(s)

• Time to ambulation — hours
  (TTA, elapsed time between removal of the final closure device or removal of final sheath and when the patient stood and walked 20 ft without evidence of venous re-bleeding from the femoral access site)

Trial sites (1)

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