Atrial FibrillationNCT04285840
Arterial Versus Venous Activated Clotting Time (ACT) Measurements During Atrial Fibrillation Ablations
A study testing Venous ACT in people with Atrial Fibrillation, run by Duke University at 1 site in United States.
Trial summary
Activated clotting times (ACTs) are routinely measured throughout atrial fibrillation ablations to monitor anticoagulation prior to and after heparin administration. Routinely, ACTs are obtained from an arterial line established prior to heparin administration. 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?
- Venous ACT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult scheduled for routine atrial ablation procedure
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arterial Versus Venous Activated Clotting Time Measurements During Atrial Fibrillation Ablations
Activated clotting times (ACTs) are routinely measured throughout atrial fibrillation ablations to monitor anticoagulation prior to and after heparin administration. Routinely, ACTs are obtained from an arterial line established prior to heparin administration. With technological advances, the cardiac intervention team is interested in eliminating the need for arterial lines for noninvasive monitoring devices; eliminating arterial lines could decrease the risk of bleeding, infection, and pain. Since procedural access requires femoral vein catheterization, obtaining ACTs through the venous sheath would not pose additional risks to the patient. In this study it proposed to draw paired arterial and venous ACT samples in ablation procedures to compare the agreement between venous and arterial ACTs for adequate patient treatment planning.
Read the detailed description
This project aims to establish a standardized procedure for venous ACT sampling during atrial fibrillation ablation in 50 adults. Analyses will examine the relationship and agreement between venous and arterial ACTs. It is anticipated that the standardized procedure could eliminate the need for an arterial line for ACT measurement which would reduce patient risks for bleeding, infection, and discomfort.
Patients who are scheduled for for atrial fibrillation ablations will be invited to participate in this project. An information sheet will be provided about the project to potential participants. If the potential participant expresses interest, a study specific consent consent will be obtained to allow the additional paired blood samples to be drawn throughout the procedure. The additional blood volume to be drawn is expected to be less than or equal to a teaspoon of venous blood. Participation will be completely voluntary.
Patients will undergo usual standard of care for the procedure, including usual arterial and venous sheath/catheter insertions. After obtaining venous and arterial access, baseline ACTs will be drawn using the outlined ACT sampling procedure. The ACT value for both arterial and venous samples will be obtained using the standard procedure for Hemochron Signature Elite point-of-care testing; this test uses less than 0.5 cc blood. ACT samples will be performed at baseline (pre-heparin administration), every 30 minutes during the procedure (per standard ACT monitoring protocol to obtain and maintain desired ACT), and at the end of procedure prior to arterial and venous sheath removal. Time of procedure ranges from 2 to 4 hours and may result in a minimum of 2 paired samples (pre and end) to a maximum of 9 paired samples (pre, end, and every 30 minutes) per patient; this equates to an additional 1 cc to 4.5 cc of additional blood for paired sampling per patient.
ACT arterial and venous sampling procedure: Using a stopcock at the nearest point of insertion, withdraw 30 cc of blood in a syringe; turn the stopcock and remove 0.5cc of blood for ACT testing; turn the stopcock to return the 30 cc blood and flush the line; remove the syringe with the ACT sample and flush the line with saline, replace syringes for the next ACT sampling process.
Patients undergoing atrial fibrillation ablations will continue to have Heparin dosed on the arterial ACT sample results only per the standard of care. Heparin will not be administered based on venous ACT levels obtained during this project. The purpose for paired sampling is to verify that the proposed venous sampling method is accurate and provides an evaluable sample to compare with the ACT sample results.
- Conditions
- Atrial Fibrillation
- Being tested
- Venous ACT
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous ACTOther
Matched/paired venous ACT samples will be drawn at the same time as arterial ACT samples to compare the results agreement between venous and arterial ACTs. Subjects undergoing atrial fibrillation ablations will continue to have Heparin dosed on the arterial ACT sample results only per the standard of care. Heparin will not be administered based on venous ACT levels obtained during this study.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Other | To establish a standardized procedure for venous ACT sampling during atrial fibrillation ablation. Analyses will examine the relationship and agreement between venous and arterial ACTs. Receives: Other: Venous ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of venous ACT samples that match arterial ACT sample results during atrial fibrillation ablation
Paired samples pre and during the ablation procedure
Measured: Day of atrial fibrillation ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start10 Feb 2020
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allen Deborah, PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285840
- Sponsor's protocol ID
- Pro00104539
- Status last verified
- Jun 2021
- First submitted
- 24 Feb 2020
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Versus Venous Activated Clotting Time Measurements During Atrial Fibrillation Ablations
- ClinicalTrials.gov ID
- NCT04285840
- Acronym / sponsor ID
- Pro00104539
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Activated clotting times (ACTs) are routinely measured throughout atrial fibrillation ablations to monitor anticoagulation prior to and after heparin administration. Routinely, ACTs are obtained from an arterial line established prior to heparin administration. With technological advances, the cardiac intervention team is interested in eliminating the need for arterial lines for noninvasive monitoring devices; eliminating arterial lines could decrease the risk of bleeding, infection, and pain. Since procedural access requires femoral vein catheterization, obtaining ACTs through the venous sheath would not pose additional risks to the patient. In this study it proposed to draw paired arterial and venous ACT samples in ablation procedures to compare the agreement between venous and arterial ACTs for adequate patient treatment planning.
Detailed description
This project aims to establish a standardized procedure for venous ACT sampling during atrial fibrillation ablation in 50 adults. Analyses will examine the relationship and agreement between venous and arterial ACTs. It is anticipated that the standardized procedure could eliminate the need for an arterial line for ACT measurement which would reduce patient risks for bleeding, infection, and discomfort.
Patients who are scheduled for for atrial fibrillation ablations will be invited to participate in this project. An information sheet will be provided about the project to potential participants. If the potential participant expresses interest, a study specific consent consent will be obtained to allow the additional paired blood samples to be drawn throughout the procedure. The additional blood volume to be drawn is expected to be less than or equal to a teaspoon of venous blood. Participation will be completely voluntary.
Patients will undergo usual standard of care for the procedure, including usual arterial and venous sheath/catheter insertions. After obtaining venous and arterial access, baseline ACTs will be drawn using the outlined ACT sampling procedure. The ACT value for both arterial and venous samples will be obtained using the standard procedure for Hemochron Signature Elite point-of-care testing; this test uses less than 0.5 cc blood. ACT samples will be performed at baseline (pre-heparin administration), every 30 minutes during the procedure (per standard ACT monitoring protocol to obtain and maintain desired ACT), and at the end of procedure prior to arterial and venous sheath removal. Time of procedure ranges from 2 to 4 hours and may result in a minimum of 2 paired samples (pre and end) to a maximum of 9 paired samples (pre, end, and every 30 minutes) per patient; this equates to an additional 1 cc to 4.5 cc of additional blood for paired sampling per patient.
ACT arterial and venous sampling procedure: Using a stopcock at the nearest point of insertion, withdraw 30 cc of blood in a syringe; turn the stopcock and remove 0.5cc of blood for ACT testing; turn the stopcock to return the 30 cc blood and flush the line; remove the syringe with the ACT sample and flush the line with saline, replace syringes for the next ACT sampling process.
Patients undergoing atrial fibrillation ablations will continue to have Heparin dosed on the arterial ACT sample results only per the standard of care. Heparin will not be administered based on venous ACT levels obtained during this project. The purpose for paired sampling is to verify that the proposed venous sampling method is accurate and provides an evaluable sample to compare with the ACT sample results.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Other | Other: Venous ACTTo establish a standardized procedure for venous ACT sampling during atrial fibrillation ablation. Analyses will examine the relationship and agreement between venous and arterial ACTs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult scheduled for routine atrial ablation procedure
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Venous ACTMatched/paired venous ACT samples will be drawn at the same time as arterial ACT samples to compare the results agreement between venous and arterial ACTs. Subjects undergoing atrial fibrillation ablations will continue to have Heparin dosed on the arterial ACT sample results only per the standard of care. Heparin will not be administered based on venous ACT levels obtained during this study. | Other | Single arm study |
Primary outcome
Proportion of venous ACT samples that match arterial ACT sample results during atrial fibrillation ablation
Time frame: Day of atrial fibrillation ablation procedure
Paired samples pre and during the ablation procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Allen Deborah, PhD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venous ACT in people with Atrial Fibrillation, run by Duke University 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 1 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 28 Jun 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of venous ACT samples that match arterial ACT sample results during atrial fibrillation ablation (time frame: Day of atrial fibrillation ablation procedure). 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 28 Jun 2021.