VASC-AF Study: Vascular Closure vs Manual Compression (VASC-AF)

February 10, 2026 updated by: Prof. Christian-Hendrik Heeger, Asklepios proresearch

Prospektiv Randomisierter Vergleich Der Manuellen Und Leistenkompression Mittels Naht Oder Einsatz Eines venösen Verschlusssystems Zur Blutstillung Nach Vorhofflimmerablation (VASC-AF)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • Recruiting
        • Asklepios Klinik Altona
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • AF ablation

Exclusion Criteria:

  • <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vascular closure
Utilizing a vascular closure system for vascular access closure
Device: Vacular closure
Vascular closure device
No Intervention: Manual
Utilizing a pressure bandage for vascular access closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to ambulation
Time Frame: 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)
hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepios proresearch

Collaborators

Haemonetics Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 1, 2025

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-101381-BO-ff

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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