Vascular closure versus manual compression after atrial fibrillation ablation
Prospektiv Randomisierter Vergleich Der Manuellen Und Leistenkompression Mittels Naht Oder Einsatz Eines venösen Verschlusssystems Zur Blutstillung Nach Vorhofflimmerablation (VASC-AF)
This will test whether the VASCADE MVP vascular closure device lets adults having pulmonary vein isolation for atrial fibrillation walk sooner than manual compression or a figure-of-8 suture.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Asklepios proresearch Industry-sponsored |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT07414121 on ClinicalTrials.gov |
What this trial studies
Adults undergoing pulmonary vein isolation for atrial fibrillation at Asklepios Klinik Altona will receive either the VASCADE MVP vascular closure device or standard manual compression/figure-of-8 suture for femoral venous access closure. The primary efficacy endpoint is time to ambulation, defined as the time from removal of the final sheath or closure device until the patient can stand and walk 20 ft without venous re-bleeding; the primary safety endpoint is major periprocedural adverse events requiring medical intervention before hospital discharge. Study staff at participating sites are trained to apply consistent endpoint definitions to preserve comparability. The trial will also record minor vascular complications and feasibility measures such as device use and need for additional hemostatic measures.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for pulmonary vein isolation (catheter ablation) for atrial fibrillation who meet local medical eligibility criteria are the intended participants.
Not a fit: People under 18, those not using femoral venous access, or patients with high bleeding risk or anatomy unsuitable for the device may not receive benefit from this approach.
Why it matters
Potential benefit: If successful, the device could let patients get out of bed and move sooner after AF ablation, shortening recovery time and potentially enabling earlier discharge.
How similar studies have performed: Vascular closure devices have been used successfully in other catheterization settings, but evidence specifically comparing venous closure devices versus manual compression after AF ablation is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * AF ablation Exclusion Criteria: * \<18 years
Where this trial is running
Hamburg
- Asklepios Klinik Altona — Hamburg, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.