StrokeINTERCEPTaviNCT05146037
INTERvention With Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (INTERCEPTavi)
A study testing CO2 and saline flushing and Saline flushing in people with Stroke and Aortic Valve Stenosis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The study aims to evaluate the processes of a pilot single-centre randomised controlled trial (RCT) of carbon-dioxide flushing of transcatheter aortic valves (TAVI-CO2) versus standard saline flushing of valves (TAVI-S) and assess potential neuroprotection through a number of neurological endpoints for planning of a… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Aortic Valve Stenosis, Silent Cerebral Infarct
- What is being tested?
- CO2 and saline flushing and Saline flushing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2021to Dec 2023
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients between the ages of 18 and 100 years undergoing transcatheter aortic valve implantation (TAVI) for aortic stenosis under local anaesthetic.
Who cannot join
- Patients that lack capacity to provide informed consent
- Patients that have had a stroke within 12 months
- Patients aged less than 18 years of age
- Patients that are pregnant
Trial locations and contacts
1 site in 1 country.
Ghada Mikhail, MD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College London
London
Saud Ahmed Khawaja, MBBS, +44 203 313 1626, Saud.khawaja@nhs.net
About this study
Official title: INTERvention With Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (INTERCEPTavi): 'Carbon-Dioxide Flushing Versus Saline Flushing of Transcatheter Aortic Valves: A Single-centre Randomised Controlled Trial'
The study aims to evaluate the processes of a pilot single-centre randomised controlled trial (RCT) of carbon-dioxide flushing of transcatheter aortic valves (TAVI-CO2) versus standard saline flushing of valves (TAVI-S) and assess potential neuroprotection through a number of neurological endpoints for planning of a full-sized RCT
Read the detailed description
Aortic stenosis (AS) is one of the most common valve diseases and is increasing worldwide due to an ageing population. Transcatheter Aortic Valve Replacement (TAVI) is a keyhole procedure that can be done through the groin to replace the narrowed aortic valve with a new valve, avoiding the need for cardiac surgery.Improved device design and greater operator experience has improved TAVI outcomes. It has become the standard treatment option in patients who are at high risk for cardiac surgery and is now being used increasingly in lower risk patients.
Cerebrovascular accidents in TAVI patients remain a significant risk with a reported 3 - 5 % risk. Furthermore, these patients have neurovascular injury that is not clinically identifiable. Covert brain injury has been identified to occur in many surgical and cardiovascular catheter-based interventions such as TAVI and can cause vascular brain injury (VBI).
TAVI valves are manufactured in room air conditions and retain air. Studies in TEVAR (Thoracic Endovascular Aortic Repair) stent grafts have shown release of air when they are deployed in the aorta. In vitro testing of TAVI valves has shown release of air when they are deployed.
Carbon-dioxide (CO2) is 1.5 times denser than air and can displace it. It is 25 times more soluble in blood than air and does not lead to bubble formation. Hence CO2 bubble are unlikely to result in significant damage. CO2 has been used in cardiac surgery with beneficial effects. It has shown to reduce peri-procedural cerebral air embolisation and post operative cognitive dysfunction.
This study aims to look at the neuroprotective benefits of flushing TAVI valves with CO2 and saline versus saline only by reducing air embolisation.
Patients undergoing TAVI will be approached to participate in this study. After consent is obtained, patients will undergo baseline MRI, neurological and neurocognitive testing pre-TAVI. Patient will be randomised to saline only or CO2 and saline flushing of their valves. During their TAVI procedure, they will have transcranial doppler (TCD) monitoring of their middle cerebral artery (MCA) bilaterally to record cerebral embolisation. Patients will also have biomarker testing pre-TAVI, post-TAVI and 24 hours following TAVI. They will have DW-MRI brain between day 1-7 following their TAVI to look for vascular brain injury. Thus MRI will be repeated at 6-months following their TAVI. Patients will also have neurological and neurocognitive testing during their inpatient admission, at 6-weeks and 6-months outpatients.
- Being tested
- CO2 and saline flushing, Saline flushing
- Keywords
- Stroke, Aortic Valve Stenosis, Silent Cerebral Infarct, Vascular Brain Injury, TAVI, Transcatheter aortic valve implantation, Transcranial doppler, Magnetic resonance imaging, CO2, Carbon dioxide
- Medical subject headings
- Stroke, Aortic Valve Stenosis, Cerebrovascular Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 and saline flushingOther
TAVI valves will be prepared by flushing with CO2 to displace any retained air during manufacturing and preparation. The valves will then be flushed with saline as per IFU.
Saline flushingOther
TAVI valves will be flushed with saline only as per IFU.
| Study group | Role | What they receive |
|---|---|---|
| Saline flushing | Active comparator | TAVI valves will be prepared according to instruction for use(IFU) with saline flushing only. Receives: Other: Saline flushing |
| CO2 and saline flushing | Experimental | TAVI valves will be flushed with CO2 and then saline as per IFU Receives: Other: CO2 and saline flushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants suitable for recruitment for larger RCT
Conduct an evaluation of the processes described in this pilot RCT for a full-scale RCT including:
- Screening, Recruitment and Randomisation
- Retention in follow-up assessments
- Study design for a full RCT and identification of important stratification variables
- Refine sample size calculation for a full RCT
Measured: Duration of study, approximately 15 months
Secondary outcomes (1)
Incidence of Vascular Brain Injury (VBI) on Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI)
Assessment of the incidence of DW-MRI detected VBI lesions following TAVI procedure. Patients will have MRI following their TAVI within 1-7 days and then at 6-months post TAVI.
Measured: Post TAVI 1-7 days and 6-months post TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Sep 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised to CO2 and Saline flushing versus saline flushing only.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Ghada Mikhail, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146037
- Sponsor's protocol ID
- 20HH6479
- Acronym
- INTERCEPTavi
- Status last verified
- Jan 2023
- First submitted
- 11 Nov 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Inci K, Koutouzi G, Chernoray V, Jeppsson A, Nilsson H, Falkenberg M. Air bubbles are released by thoracic endograft deployment: An in vitro experimental study. SAGE Open Med. 2016 Dec 7;4:2050312116682130. doi: 10.1177/2050312116682130. eCollection 2016.
PubMed 27994872Rohlffs F, Tsilimparis N, Saleptsis V, Diener H, Debus ES, Kolbel T. Air Embolism During TEVAR: Carbon Dioxide Flushing Decreases the Amount of Gas Released from Thoracic Stent-Grafts During Deployment. J Endovasc Ther. 2017 Feb;24(1):84-88. doi: 10.1177/1526602816675621. Epub 2016 Oct 26.
PubMed 27798380Martens S, Neumann K, Sodemann C, Deschka H, Wimmer-Greinecker G, Moritz A. Carbon dioxide field flooding reduces neurologic impairment after open heart surgery. Ann Thorac Surg. 2008 Feb;85(2):543-7. doi: 10.1016/j.athoracsur.2007.08.047.
PubMed 18222261Bismuth J, Garami Z, Anaya-Ayala JE, Naoum JJ, El Sayed HF, Peden EK, Lumsden AB, Davies MG. Transcranial Doppler findings during thoracic endovascular aortic repair. J Vasc Surg. 2011 Aug;54(2):364-9. doi: 10.1016/j.jvs.2010.12.063. Epub 2011 Mar 3.
PubMed 21371850Perera AH, Rudarakanchana N, Monzon L, Bicknell CD, Modarai B, Kirmi O, Athanasiou T, Hamady M, Gibbs RG. Cerebral embolization, silent cerebral infarction and neurocognitive decline after thoracic endovascular aortic repair. Br J Surg. 2018 Mar;105(4):366-378. doi: 10.1002/bjs.10718. Epub 2018 Feb 12.
PubMed 29431856
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTERvention With Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (INTERCEPTavi): 'Carbon-Dioxide Flushing Versus Saline Flushing of Transcatheter Aortic Valves: A Single-centre Randomised Controlled Trial'
- ClinicalTrials.gov ID
- NCT05146037
- Acronym / sponsor ID
- INTERCEPTavi / 20HH6479
- Keywords
- Stroke, Aortic Valve Stenosis, Silent Cerebral Infarct, Vascular Brain Injury, TAVI, Transcatheter aortic valve implantation, Transcranial doppler, Magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Dec 2021 (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.
The study aims to evaluate the processes of a pilot single-centre randomised controlled trial (RCT) of carbon-dioxide flushing of transcatheter aortic valves (TAVI-CO2) versus standard saline flushing of valves (TAVI-S) and assess potential neuroprotection through a number of neurological endpoints for planning of a full-sized RCT
Detailed description
Aortic stenosis (AS) is one of the most common valve diseases and is increasing worldwide due to an ageing population. Transcatheter Aortic Valve Replacement (TAVI) is a keyhole procedure that can be done through the groin to replace the narrowed aortic valve with a new valve, avoiding the need for cardiac surgery.Improved device design and greater operator experience has improved TAVI outcomes. It has become the standard treatment option in patients who are at high risk for cardiac surgery and is now being used increasingly in lower risk patients.
Cerebrovascular accidents in TAVI patients remain a significant risk with a reported 3 - 5 % risk. Furthermore, these patients have neurovascular injury that is not clinically identifiable. Covert brain injury has been identified to occur in many surgical and cardiovascular catheter-based interventions such as TAVI and can cause vascular brain injury (VBI).
TAVI valves are manufactured in room air conditions and retain air. Studies in TEVAR (Thoracic Endovascular Aortic Repair) stent grafts have shown release of air when they are deployed in the aorta. In vitro testing of TAVI valves has shown release of air when they are deployed.
Carbon-dioxide (CO2) is 1.5 times denser than air and can displace it. It is 25 times more soluble in blood than air and does not lead to bubble formation. Hence CO2 bubble are unlikely to result in significant damage. CO2 has been used in cardiac surgery with beneficial effects. It has shown to reduce peri-procedural cerebral air embolisation and post operative cognitive dysfunction.
This study aims to look at the neuroprotective benefits of flushing TAVI valves with CO2 and saline versus saline only by reducing air embolisation.
Patients undergoing TAVI will be approached to participate in this study. After consent is obtained, patients will undergo baseline MRI, neurological and neurocognitive testing pre-TAVI. Patient will be randomised to saline only or CO2 and saline flushing of their valves. During their TAVI procedure, they will have transcranial doppler (TCD) monitoring of their middle cerebral artery (MCA) bilaterally to record cerebral embolisation. Patients will also have biomarker testing pre-TAVI, post-TAVI and 24 hours following TAVI. They will have DW-MRI brain between day 1-7 following their TAVI to look for vascular brain injury. Thus MRI will be repeated at 6-months following their TAVI. Patients will also have neurological and neurocognitive testing during their inpatient admission, at 6-weeks and 6-months outpatients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomised to CO2 and Saline flushing versus saline flushing only.
| Arm | Type | Receives |
|---|---|---|
| Saline flushing | Active comparator | Other: Saline flushingTAVI valves will be prepared according to instruction for use(IFU) with saline flushing only. |
| CO2 and saline flushing | Experimental | Other: CO2 and saline flushingTAVI valves will be flushed with CO2 and then saline as per IFU |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients between the ages of 18 and 100 years undergoing transcatheter aortic valve implantation (TAVI) for aortic stenosis under local anaesthetic.
Key exclusion criteria (4 listed)
- Patients that lack capacity to provide informed consent
- Patients that have had a stroke within 12 months
- Patients aged less than 18 years of age
- Patients that are pregnant
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 |
|---|---|---|
| CO2 and saline flushingTAVI valves will be prepared by flushing with CO2 to displace any retained air during manufacturing and preparation. The valves will then be flushed with saline as per IFU. | Other | CO2 and saline flushing |
| Saline flushingTAVI valves will be flushed with saline only as per IFU. | Other | Saline flushing |
Primary outcome
Number of participants suitable for recruitment for larger RCT
Time frame: Duration of study, approximately 15 months
Conduct an evaluation of the processes described in this pilot RCT for a full-scale RCT including: 1. Screening, Recruitment and Randomisation 2. Retention in follow-up assessments 3. Study design for a full RCT and identification of important stratification variables 4. Refine sample size calculation for a full RCT
1 secondary outcome
Incidence of Vascular Brain Injury (VBI) on Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI)
Time frame: Post TAVI 1-7 days and 6-months post TAVI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Background: PubMed 27994872Inci K, Koutouzi G, Chernoray V, Jeppsson A, Nilsson H, Falkenberg M. Air bubbles are released by thoracic endograft deployment: An in vitro experimental study. SAGE Open Med. 2016 Dec 7;4:2050312116682130. doi: 10.1177/2050312116682130. eCollection 2016.
- Background: PubMed 27798380Rohlffs F, Tsilimparis N, Saleptsis V, Diener H, Debus ES, Kolbel T. Air Embolism During TEVAR: Carbon Dioxide Flushing Decreases the Amount of Gas Released from Thoracic Stent-Grafts During Deployment. J Endovasc Ther. 2017 Feb;24(1):84-88. doi: 10.1177/1526602816675621. Epub 2016 Oct 26.
- Background: PubMed 18222261Martens S, Neumann K, Sodemann C, Deschka H, Wimmer-Greinecker G, Moritz A. Carbon dioxide field flooding reduces neurologic impairment after open heart surgery. Ann Thorac Surg. 2008 Feb;85(2):543-7. doi: 10.1016/j.athoracsur.2007.08.047.
- Background: PubMed 21371850Bismuth J, Garami Z, Anaya-Ayala JE, Naoum JJ, El Sayed HF, Peden EK, Lumsden AB, Davies MG. Transcranial Doppler findings during thoracic endovascular aortic repair. J Vasc Surg. 2011 Aug;54(2):364-9. doi: 10.1016/j.jvs.2010.12.063. Epub 2011 Mar 3.
- Background: PubMed 29431856Perera AH, Rudarakanchana N, Monzon L, Bicknell CD, Modarai B, Kirmi O, Athanasiou T, Hamady M, Gibbs RG. Cerebral embolization, silent cerebral infarction and neurocognitive decline after thoracic endovascular aortic repair. Br J Surg. 2018 Mar;105(4):366-378. doi: 10.1002/bjs.10718. Epub 2018 Feb 12.
- Individual participant dataSharing planned: Undecided
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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.
Ghada Mikhail, MD contact
Ghada Mikhail principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 and saline flushing and Saline flushing in people with Stroke and Aortic Valve Stenosis, run by Imperial College London at 1 site in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 26 Jan 2023. 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 Kingdom. 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 Saud Ahmed Khawaja, MBBS (+44 203 313 1626, Saud.khawaja@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants suitable for recruitment for larger RCT (time frame: Duration of study, approximately 15 months). 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 NCT05146037, which also lists 5 linked publications.
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 26 Jan 2023.