Atrial FibrillationFigure 8NCT03040661
Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture
A study testing Ablation for atrial fibrillation. in people with Atrial Fibrillation, run by Inova Health Care Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Ablation for atrial fibrillation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient who meets standard clinical criteria for an ablation of AF with Cryoballoon, and is to undergo the procedure
Who cannot join
- Pregnant patients.
- Age <18 years.
- Patients who cannot provide consent in English.
- Prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Fairfax Hospital
Falls Church, Virginia, 22042
About this study
Official title: Randomized Trial of 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 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).
- Conditions
- Atrial Fibrillation
- Being tested
- Ablation for atrial fibrillation.
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation for atrial fibrillation.Procedure or surgery
Ablation for atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Figure of 8 Suture | Experimental | Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture. Receives: Procedure: Ablation for atrial fibrillation. |
| Manual Hemostasis Group | Active comparator | Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique. Receives: Procedure: Ablation for atrial fibrillation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Required to Achieve Hemostasis
Time Required to Achieve Hemostasis (minutes)
Measured: Time (minutes) from sheath removal till hemostasis achieved
Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.
Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes)
Measured: Time (minutes) from completion of procedure till patient leaves room
Secondary outcomes (1)
Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group
Percent groin complications ( major or minor bleeding, additional pressure required for hemostasis, hematoma, pseudoaneurysm, and transfusion) in Figure of 8 suture technique group compared to manual hemostasis group.
Measured: Assessed after sheath removal till patient discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Mar 2017
- Primary completion1 Mar 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040661
- Sponsor's protocol ID
- 16-2381
- Acronym
- Figure 8
- Status last verified
- Dec 2021
- First submitted
- 24 Jan 2017
- Last updated
- 11 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture
- ClinicalTrials.gov ID
- NCT03040661
- Acronym / sponsor ID
- Figure 8 / 16-2381
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Posted 11 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Figure of 8 Suture | Experimental | Procedure: Ablation for atrial fibrillation.Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture. |
| Manual Hemostasis Group | Active comparator | Procedure: Ablation for atrial fibrillation.Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient who meets standard clinical criteria for an ablation of AF with Cryoballoon, and is to undergo the procedure
Key exclusion criteria (4 listed)
- Pregnant patients.
- Age <18 years.
- Patients who cannot provide consent in English.
- Prisoners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation for atrial fibrillation.Ablation for atrial fibrillation. | Procedure or surgery | Figure of 8 Suture, Manual Hemostasis Group |
Primary outcome
Time Required to Achieve Hemostasis
Time frame: Time (minutes) from sheath removal till hemostasis achieved
Time Required to Achieve Hemostasis (minutes)
Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.
Time frame: Time (minutes) from completion of procedure till patient leaves room
Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes)
1 secondary outcome
Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group
Time frame: Assessed after sheath removal till patient discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation for atrial fibrillation. in people with Atrial Fibrillation, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Required to Achieve Hemostasis (time frame: Time (minutes) from sheath removal till hemostasis achieved). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.