Vascular Closure
Conditions
Brief summary
A multi-center, prospective, single-arm 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, performed through 6 - 12 Fr inner diameter (maximum 15F OD) introducer sheaths.
Interventions
DEVICEFemoral Venous Vascular Closure
Femoral venous vascular closure following catheter-based cardiac ablation a-fib cases utilizing 6-12 French inner diameter procedural sheaths at time of closure.
Sponsors
Cardiva Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Group 1 Paroxysmal AF Inclusion Criteria: 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: All criteria apply: 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 Note: Initial subject eligibility will be determined based on pre-operative screening. Final subject enrollment will be determined at the end the procedure, prior to closure, based on general intra-op
Exclusion criteria
, as well as additional intraoperative criteria. Enrollment is thus determined intra-operatively, at the end of the case and just prior to closure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VASCADE MVP VVCS Procedure Success | 1 day | Patients do not require next day hospital intervention\* due to access site-related complications. |
| Major Complication Rate | 15 Days +/- 5 Days | On a per-limb basis, the rate of combined major venous access site closure-related complications attributed directly to the closure method within 15 ± 5 days of discharge (i.e., device-related with no other likely attributable cause). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Same Day Procedure Success | 1 day | Patients do not require next day hospital intervention for any procedure-related reason. |
| Sustained VASCADE MVP VVCS Procedure Success | 15 Days +/- 5 Days | Patients do not require hospital intervention within 15 days of discharge due to access site-related complications. |
| Device Success | intra-procedural | The ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the VASCADE MVP VVCS. |
| Minor Complication Rate | 15 Days +/- 5 Days | On a per-limb basis, the rate of combined minor venous access site closure-related complications attributed directly to the closure method (i.e., device-related with no other likely attributable cause. |
Countries
United States
Outcome results
None listed