NCT07414121 VASC-AF Study: Vascular Closure vs Manual Compression
| NCT ID | NCT07414121 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asklepios proresearch |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-04-22 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * AF ablation Exclusion Criteria: * \<18 years
Frequently Asked Questions
Who can join the NCT07414121 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 95 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07414121 currently recruiting?
Yes, NCT07414121 is actively recruiting participants. Visit ClinicalTrials.gov or contact Asklepios proresearch to inquire about joining.
Where is the NCT07414121 trial being conducted?
This trial is being conducted at Hamburg, Germany.
Who is sponsoring the NCT07414121 clinical trial?
NCT07414121 is sponsored by Asklepios proresearch. The trial plans to enroll 100 participants.
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