N/A
N=70
Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03040661 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Time Required to Achieve Hemostasis — 0; 15 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ablation for atrial fibrillation. (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Inova Health Care Services
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Required to Achieve Hemostasis |
0; 15 | — |
| PRIMARY Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab. |
20; 28 | — |
| SECONDARY Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group |
8.6; 34.2 | — |
Summary
Patients who undergo ablation for AF typically have 2 sheaths placed in each groin, including a large sheath when the Cryo Balloon is used for pulmonary vein isolation. During the procedure, heparin is administered to maintain a target ACT > 300 seconds. At the conclusion of the procedure, the venous sheaths are removed and hemostasis is obtained. There are at least 2 ways of obtaining hemostasis after venous access. In the manual hemostasis approach, an ACT is checked and protamine is administered. The ACT is rechecked 20" later, and if < 220 msec, the sheaths are pulled and hemostasis is achieved with manual pressure (Manual Hemostasis Group). Another approach is to place a Figure of 8 suture around the sheaths in each groin to achieve hemostasis as the sheaths are removed, and therefore obviate the need for assessment of the ACT, protamine administration, and manual pressure (Figure of 8 Group).
Eligibility Criteria
Inclusion Criteria
- Any patient who meets standard clinical criteria for an ablation of AF with Cryoballoon, and is to undergo the procedure
Exclusion Criteria
- Pregnant patients.
- Age <18 years.
- Patients who cannot provide consent in English.
- Prisoners.
Data sourced from ClinicalTrials.gov (NCT03040661). 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.