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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 is a NA study that has completed, run by Inova Health Care Services. The registered enrollment target is 70 participants.

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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).

Interventions

  • PROCEDURE Ablation for atrial fibrillation.

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2017-03-01
Est. Completion 2018-06-01
Phase NA

Sponsor

Inova Health Care Services

75 total trials

What the Registry Record Tells You About NCT03040661

The ClinicalTrials.gov registry entry for NCT03040661 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inova Health Care Services, which has 75 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Ablation for atrial fibrillation. is the first listed.

NCT03040661 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.