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NCT03040661 · ClinicalTrials.gov registry record · NA
Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture
A NA study, sponsored by Inova Health Care Services.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
NCT03040661: Completed NA study, sponsored by Inova Health Care Services.
NCT03040661 is a NA study that has completed, run by Inova Health Care Services. The registered enrollment target is 70 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03040661, a NA study, has completed, sponsored by Inova Health Care Services.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
Study 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).
Primary Outcome
Time Required to Achieve Hemostasis (minutes)
Interventions
- PROCEDURE Ablation for atrial fibrillation.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2018-06-01 |
| Phase | NA |
What the finished NCT03040661 record still lists
NCT03040661 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Ablation for atrial fibrillation. is the first listed.
NCT03040661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03040661 about?
NCT03040661 is a clinical study titled "Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture". 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 veno...
What is the current status of trial NCT03040661?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2017-03-01. Estimated completion is 2018-06-01.
What interventions are being tested in trial NCT03040661?
The interventions under investigation include: Ablation for atrial fibrillation. (PROCEDURE).
Who is sponsoring clinical trial NCT03040661?
This trial is sponsored by Inova Health Care Services, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03040661's enrollment target sits among peer trials
70 1103rd of 2000 higher than 868 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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