An interventional study of Vacular closure in Atrial Fibrillation, sponsored by Asklepios proresearch. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Asklepios proresearch · Not applicable, Interventional, and Treatment
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
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 100 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Asklepios proresearch is the lead sponsor of 17 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Utilizing a vascular closure system for vascular access closure
Device: Vacular closure
Utilizing a pressure bandage for vascular access closure
Vascular closure device
Time to ambulation
(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)
Time frame: hours
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Asklepios proresearch