VASCADE

A Multi-center, Prospective, Single-Arm Registry to Evaluate Procedural Outcomes Using the Cardiva VASCADE MVP VVCS Closure Device After Catheter-based Atrial Fibrillation Interventions for Patients Who Are Discharged the Same Day.

Objective

A post-market registry, designed to collect both performance and complication outcomes when same-day discharge is enabled by the study device, in sealing multiple femoral venous access sites at the completion of ablation procedures for atrial fibrillation with or without another arrhythmia.

Eligibility

Pre-Operative Inclusion:

All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:

  1. ≥18 years of age;
  2. Capable and willing to give informed consent;
  3. Acceptable candidate for an elective, non-emergent catheter-based paroxysmal atrial fibrillation ablation procedure with or without another arrhythmia via the common femoral vein(s) using a 6 to 12 Fr inner diameter (max 15F OD) introducer sheath
  4. Is accompanied by a person who will be available to assist the subject for 24 hours post-procedure and/or has access to emergency services;
  5. Is willing/able to stay overnight at the hospital per physician discretion.
  6. Able and willing to complete two follow-up contacts at 2-4 days and 15 (± 5) days post-procedure.
  7. Acceptable candidate for emergent vascular surgery, and/or manual compression of the venous access site;

Intra-Operative Inclusion:

  1. In the Investigator's opinion, the subject is a candidate for Same Day Discharge per protocol (e.g., no new pericardial effusion, post-procedure diuresis not needed, etc.).
  2. Physician or designee will be on site for discharge evaluation.
  3. Case completed in time for subject to be reasonably recovered and discharged according to protocol.
  4. All femoral venous access sites are planned to be closed with the MVP

NCT ID

NCT04203329