Atrial FibrillationVASC-AFNCT07414121
VASC-AF Study: Vascular Closure vs Manual Compression
A study testing Vacular closure in people with Atrial Fibrillation, run by Asklepios proresearch at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Vacular closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 22 Apr 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AF ablation
Who cannot join
- <18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Asklepios Klinik Altona
Hamburg
Christian-Hendrik Heeger, Prof. Dr., 0049401818818904, c.heeger@asklepios.com
About this study
Official title: 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.
Read more
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
- Conditions
- Atrial Fibrillation
- Being tested
- Vacular closure
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacular closureDevice
Vascular closure device
| Study group | Role | What they receive |
|---|---|---|
| vascular closure | Experimental | Utilizing a vascular closure system for vascular access closure Receives: Device: Vacular closure |
| Manual | No intervention | Utilizing a pressure bandage for vascular access closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start22 Apr 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asklepios proresearch
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Haemonetics Corporation
- Responsible party
- Principal investigator, Prof. Christian-Hendrik Heeger, Asklepios proresearch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414121
- Sponsor's protocol ID
- 2024-101381-BO-ff
- Acronym
- VASC-AF
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospektiv Randomisierter Vergleich Der Manuellen Und Leistenkompression Mittels Naht Oder Einsatz Eines venösen Verschlusssystems Zur Blutstillung Nach Vorhofflimmerablation (VASC-AF)
- ClinicalTrials.gov ID
- NCT07414121
- Acronym / sponsor ID
- VASC-AF / 2024-101381-BO-ff
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asklepios proresearchIndustry (pharma, biotech, devices)
- Collaborators
- Haemonetics Corporation
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vascular closure | Experimental | Device: Vacular closureUtilizing a vascular closure system for vascular access closure |
| Manual | No intervention | –Utilizing a pressure bandage for vascular access closure |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- AF ablation
Key exclusion criteria (1 listed)
- <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacular closureVascular closure device | Device | vascular closure |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacular closure in people with Atrial Fibrillation, run by Asklepios proresearch at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to ambulation (time frame: hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.