Ultrasound Therapy; Complications3D-US-TAVINCT04691245
3D US Guided Femoral Artery Access for TAVI
A study testing 3D US and 2D US in people with Ultrasound Therapy; Complications and Femoral Artery Injury, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
Rationale: Bleeding and vascular complications of the femoral artery still account for significant morbidity and mortality in transcatheter aortic valve implantation procedures. Although steadily declining over the past years through smaller diameter devices and use of ultrasound, major complications still occur in… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ultrasound Therapy; Complications, Femoral Artery Injury
- What is being tested?
- 3D US and 2D US
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2021to Dec 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult age (>18 years)
- Scheduled to undergo elective transcatheter aortic valve implantation with percutaneous access through the femoral artery
- Written Informed consent
Who cannot join
- Unable to obtain informed consent
- Vascular access via alternative approach (radial/subclavian) or surgical cutdown
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, 5623 EJ
Harm Scholten, MSc, +31402398500, harm.scholten@catharinaziekenhuis.nl
About this study
Official title: Three Dimensional Ultrasound Guided Femoral Access for Transcatheter Aortic Valve Implantation
Rationale: Bleeding and vascular complications of the femoral artery still account for significant morbidity and mortality in transcatheter aortic valve implantation procedures. Although steadily declining over the past years through smaller diameter devices and use of ultrasound, major complications still occur in 3-4 % of patients. Femoral access is often obtained using 2D US guidance already. New 3D US probes can aid in increasing anatomical awareness. This can improve first pass success during procedures. Furthermore, for new closure devices, entering the artery at a straight angle at precisely 12 o'clock probably reduces complications. Therefore, the investigators hypothesize improved real time needle guidance using three dimensional ultrasound can decrease procedure related complications.
- Being tested
- 3D US, 2D US
- Keywords
- 3D Ultrasound, vascular access, Transcatheter aortic valve implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D USDevice
3D US guided access to femoral artery
2D USDevice
2D US guided access to femoral artery
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Femoral access using 3D US Receives: Device: 3D US |
| Control | Active comparator | Femoral access using 2D US Receives: Device: 2D US |
What is being measured
The primary outcome is the main question the study is designed to answer.
first pass success
successful entry in femoral artery within one skinbreak and without needle redirections
Measured: during procedure/surgery
Secondary outcomes (7)
imaging time
time from putting probe on skin to start procedure (in seconds)
Measured: during procedure/surgery
procedure time
time from puncturing skin until entry in femoral artery (in seconds)
Measured: during procedure/surgery
total number of punctures
new skin breaks needed for completion of procedure
Measured: during procedure/surgery
number of needle redirections
total number of needle withdrawals >5mm but without needing new skin puncture
Measured: during procedure/surgery
12 o clock entry
entrance to femoral artery at exactly 12 o clock (antero-medial)
Measured: during procedure/surgery
needle visualization
rated from good-adequate-poor
Measured: during procedure/surgery
operator satisfaction
likert scale 1-5 with 1 no satisfaction and 5 completely satisfied
Measured: during procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study startFeb 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Therapy; ComplicationsStudies 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
- Model description
- randomized clinical trial with two arms
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Eindhoven University of Technology
- Responsible party
- Principal investigator, Harm Scholten, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691245
- Sponsor's protocol ID
- 3D-US-TAVI
- Acronym
- 3D-US-TAVI
- Status last verified
- Dec 2020
- First submitted
- 20 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Ultrasound Guided Femoral Access for Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT04691245
- Acronym / sponsor ID
- 3D-US-TAVI / 3D-US-TAVI
- Keywords
- 3D Ultrasound, vascular access, Transcatheter aortic valve implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Eindhoven University of Technology
- Study start
- Feb 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 31 Dec 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.
Rationale: Bleeding and vascular complications of the femoral artery still account for significant morbidity and mortality in transcatheter aortic valve implantation procedures. Although steadily declining over the past years through smaller diameter devices and use of ultrasound, major complications still occur in 3-4 % of patients. Femoral access is often obtained using 2D US guidance already. New 3D US probes can aid in increasing anatomical awareness. This can improve first pass success during procedures. Furthermore, for new closure devices, entering the artery at a straight angle at precisely 12 o'clock probably reduces complications. Therefore, the investigators hypothesize improved real time needle guidance using three dimensional ultrasound can decrease procedure related complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial with two arms
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: 3D USFemoral access using 3D US |
| Control | Active comparator | Device: 2D USFemoral access using 2D US |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult age (>18 years)
- Scheduled to undergo elective transcatheter aortic valve implantation with percutaneous access through the femoral artery
- Written Informed consent
Key exclusion criteria (2 listed)
- Unable to obtain informed consent
- Vascular access via alternative approach (radial/subclavian) or surgical cutdown
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 |
|---|---|---|
| 3D US3D US guided access to femoral artery | Device | Intervention |
| 2D US2D US guided access to femoral artery | Device | Control |
Primary outcome
first pass success
Time frame: during procedure/surgery
successful entry in femoral artery within one skinbreak and without needle redirections
7 secondary outcomes
imaging time
Time frame: during procedure/surgery
procedure time
Time frame: during procedure/surgery
total number of punctures
Time frame: during procedure/surgery
number of needle redirections
Time frame: during procedure/surgery
12 o clock entry
Time frame: during procedure/surgery
needle visualization
Time frame: during procedure/surgery
operator satisfaction
Time frame: during procedure/surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D US and 2D US in people with Ultrasound Therapy; Complications and Femoral Artery Injury, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Dec 2020. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harm Scholten, MD (0031402398500 ext. 2211, harm.scholten@cze.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first pass success (time frame: during procedure/surgery). 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 31 Dec 2020.