Atrial FibrillationULTRA-FASTNCT02834221
Ultrasound-guided Femoral Vein Accessibility, Safety and Time for Atrial Fibrillation Treatment
A study testing Real-time ultrasound-guided puncture and Anatomical landmark guided puncture in people with Atrial Fibrillation and Peripheral Vascular Disease, run by Kenichiro Yamagata at 4 sites in 2 countries.
Trial summary
This study is designed to evaluate the use of real-time ultrasound-guided femoral venipuncture during pulmonary vein isolation for treating atrial fibrillation . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Peripheral Vascular Disease, Vascular Access Complications
- What is being tested?
- Real-time ultrasound-guided puncture and Anatomical landmark guided puncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2016to Nov 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for atrial fibrillation treatment.
Who cannot join
- Patients with prior known vascular access problems or priory included to the current study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Czechia3 sites
Regional Hospital Liberec
Liberec, 46001
Institute for Clinical and Experimental Medicine
Prague, 14021
Ústřední vojenská nemocnice
Prague, 16902
About this study
Official title: Ultrasound-guided or Anatomical Femoral Venipuncture for Pulmonary Vein Isolation for Atrial Fibrillation Treatment
This study is designed to evaluate the use of real-time ultrasound-guided femoral venipuncture during pulmonary vein isolation for treating atrial fibrillation .
Read the detailed description
The number of pulmonary vein isolation (PVI) therapy for atrial fibrillation (AF) is increasing. Multiple femoral vein cannulation is mandatory for this procedure. There are mainly two methods to cannulate the femoral vein; by anatomical landmark or by under real-time ultrasound-guided. As high anticoagulant level is required for the procedure, there are 0-13% of vascular access complication.
Real-time ultrasound assistance for central venous catheter cannulation has been proven to reduce complications. In the field of AF treatment, multiple femoral vein cannulation is required as many catheter is required for the procedure and larger sheaths are inserted with a high anticoagulant level during the procedure. In this setting, the use of ultrasound use is not well studied.
The current study is to confirm whether real time ultrasound-guided femoral vein cannulation for PVI can prevent complications, reduce puncture time, puncture attempts and accidental artery puncture compared to conventional anatomical approach. Two seethes for each femoral vein is going to be cannulated.
The study design is a multicenter prospective randomized trial to compare the above safety and efficacy by using the ultrasound-guided and anatomical landmark approach. Also time for cannulation, number of puncture attempts, need of X-ray for cannulation will be analyzed in the setting of patient factors including age, body mass index and sex.
- Being tested
- Real-time ultrasound-guided puncture, Anatomical landmark guided puncture
- Keywords
- Femoral vein puncture
- Medical subject headings
- Atrial Fibrillation, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time ultrasound-guided punctureDevice
A 7 megahertz ultrasound linear probe will be used.
Anatomical landmark guided punctureOther
Anatomical landmark puncture
| Study group | Role | What they receive |
|---|---|---|
| Real-time ultrasound-guided puncture | Experimental | Cannulate each femoral veins with two wires with real-time ultrasound-guided method. Receives: Device: Real-time ultrasound-guided puncture |
| Anatomical landmark guided puncture | Other | Cannulate each femoral veins with two wires with the anatomical landmark guided method. Receives: Other: Anatomical landmark guided puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complications
Total patient number of vascular complications requiring surgical treatment, retroperitoneal hematoma requiring blood transfusion or hemoglobin drop of 3 >g/dl, strong pain at the groin, prolonging hospital stay and requiring hospital admission after discharge.
Measured: After the puncture up to 12 weeks
Secondary outcomes (5)
Unsuccessful femoral vein cannulation
Number of patients with unsuccessful femoral vein cannulation defined as crossing over to the other randomized method or change of operator to cannulate all wires.
Measured: Immediately after the puncture
Number of puncture attempts
Number of puncture attempts to cannulate all wires.
Measured: Immediately after the puncture
Total puncture time
Time from giving anesthesia to the groin till confirming all wires in the infra vena cava with the X-ray.
Measured: Immediately after the puncture
Number of artery mis-punctures
Number of artery mis-punctures attempts to cannulate all wires.
Measured: Immediately after the puncture
Use of X-ray for successful wire cannulation
If there is a need of X-ray to cannulate the wire into the infra vena cava.
Measured: Immediately after the puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenichiro Yamagata
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Kenichiro Yamagata, Institute for Clinical and Experimental Medicine
- Investigators
- Joseph Kautzner, MD, PhD, Study director, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834221
- Sponsor's protocol ID
- ULTRA-FAST
- Acronym
- ULTRA-FAST
- Status last verified
- Jun 2017
- First submitted
- 29 Jun 2016
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yamagata K, Wichterle D, Roubicek T, Jarkovsky P, Sato Y, Kogure T, Peichl P, Konecny P, Jansova H, Kucera P, Aldhoon B, Cihak R, Sugimura Y, Kautzner J. Ultrasound-guided versus conventional femoral venipuncture for catheter ablation of atrial fibrillation: a multicentre randomized efficacy and safety trial (ULTRA-FAST trial). Europace. 2018 Jul 1;20(7):1107-1114. doi: 10.1093/europace/eux175.
PubMed 28575490
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided or Anatomical Femoral Venipuncture for Pulmonary Vein Isolation for Atrial Fibrillation Treatment
- ClinicalTrials.gov ID
- NCT02834221
- Acronym / sponsor ID
- ULTRA-FAST / ULTRA-FAST
- Keywords
- Femoral vein puncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Kenichiro YamagataOther government
- Study start
- Jun 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Jul 2016 (estimated)
- 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.
This study is designed to evaluate the use of real-time ultrasound-guided femoral venipuncture during pulmonary vein isolation for treating atrial fibrillation .
Detailed description
The number of pulmonary vein isolation (PVI) therapy for atrial fibrillation (AF) is increasing. Multiple femoral vein cannulation is mandatory for this procedure. There are mainly two methods to cannulate the femoral vein; by anatomical landmark or by under real-time ultrasound-guided. As high anticoagulant level is required for the procedure, there are 0-13% of vascular access complication.
Real-time ultrasound assistance for central venous catheter cannulation has been proven to reduce complications. In the field of AF treatment, multiple femoral vein cannulation is required as many catheter is required for the procedure and larger sheaths are inserted with a high anticoagulant level during the procedure. In this setting, the use of ultrasound use is not well studied.
The current study is to confirm whether real time ultrasound-guided femoral vein cannulation for PVI can prevent complications, reduce puncture time, puncture attempts and accidental artery puncture compared to conventional anatomical approach. Two seethes for each femoral vein is going to be cannulated.
The study design is a multicenter prospective randomized trial to compare the above safety and efficacy by using the ultrasound-guided and anatomical landmark approach. Also time for cannulation, number of puncture attempts, need of X-ray for cannulation will be analyzed in the setting of patient factors including age, body mass index and sex.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time ultrasound-guided puncture | Experimental | Device: Real-time ultrasound-guided punctureCannulate each femoral veins with two wires with real-time ultrasound-guided method. |
| Anatomical landmark guided puncture | Other | Other: Anatomical landmark guided punctureCannulate each femoral veins with two wires with the anatomical landmark guided method. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for atrial fibrillation treatment.
Key exclusion criteria (1 listed)
- Patients with prior known vascular access problems or priory included to the current study.
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 |
|---|---|---|
| Real-time ultrasound-guided punctureA 7 megahertz ultrasound linear probe will be used. | Device | Real-time ultrasound-guided puncture |
| Anatomical landmark guided punctureAnatomical landmark puncture | Other | Anatomical landmark guided puncture |
Primary outcome
Major complications
Time frame: After the puncture up to 12 weeks
Total patient number of vascular complications requiring surgical treatment, retroperitoneal hematoma requiring blood transfusion or hemoglobin drop of 3 >g/dl, strong pain at the groin, prolonging hospital stay and requiring hospital admission after discharge.
5 secondary outcomes
Unsuccessful femoral vein cannulation
Time frame: Immediately after the puncture
Number of puncture attempts
Time frame: Immediately after the puncture
Total puncture time
Time frame: Immediately after the puncture
Number of artery mis-punctures
Time frame: Immediately after the puncture
Use of X-ray for successful wire cannulation
Time frame: Immediately after the puncture
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 7 Jun 2017.
- Results publication: PubMed 28575490Yamagata K, Wichterle D, Roubicek T, Jarkovsky P, Sato Y, Kogure T, Peichl P, Konecny P, Jansova H, Kucera P, Aldhoon B, Cihak R, Sugimura Y, Kautzner J. Ultrasound-guided versus conventional femoral venipuncture for catheter ablation of atrial fibrillation: a multicentre randomized efficacy and safety trial (ULTRA-FAST trial). Europace. 2018 Jul 1;20(7):1107-1114. doi: 10.1093/europace/eux175.
- Individual participant dataSharing planned: No
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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.
Joseph Kautzner, MD, PhD study director
Institute for Clinical and Experimental Medicine
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time ultrasound-guided puncture and Anatomical landmark guided puncture in people with Atrial Fibrillation and Peripheral Vascular Disease, run by Kenichiro Yamagata at 4 sites in 2 countries.
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 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia, Japan. 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?
Major complications (time frame: After the puncture up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02834221, which also lists 1 linked publication.
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 7 Jun 2017.