N/A
N=434
VAscular Closure for Cardiac Ablation Registry (VACCAR)
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03546439 ↗Enrolled (actual)
434
Serious AEs
0.2%
Results posted
Mar 2022
Primary outcome: Primary: Hemostasis — 9; 20; 7 minutes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Saint Luke's Health System
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemostasis |
9; 20; 7 | — |
| PRIMARY Ambulation |
2.2; 6.5; 2.2 | — |
| PRIMARY Complications |
3; 5; 3 | — |
| PRIMARY Hospital Stay |
29; 29; 27.5 | — |
Summary
The objective of this registry is to find out if there is a difference in patient satisfaction and rate of vascular and bleeding complications with use of Perclose Proglide system or F08S for venous closure post atrial fibrillation and atrial flutter procedures in comparison to manual compression.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing a catheter ablation procedure (radiofrequency ablation or cryoablation) to treat symptomatic paroxysmal atrial fibrillation or atrial flutter
- Patients willing to participate in a short written survey
Exclusion Criteria
- Patients undergoing ablation for an arrhythmia other than atrial fibrillation/atrial flutter or who are not candidates for an ablation procedure for treatment of atrial fibrillation/atrial flutter
- Patients who are not able to read or understand the English language
- Patients who had recent access site complications within the same hospitalization
- Patients who have baseline thrombocytopenia (platelet count less than 80) or known coagulopathy (INR > 1.5)
Data sourced from ClinicalTrials.gov (NCT03546439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.