Aortic StenosisNCT01237743
Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation.
An observational study of Aortic Stenosis, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Transcatheter Aortic Valve Implantation (TAVI) using femoral access is an option for definitive treatment of aortic stenosis when open-heart surgery is considered inappropriate. By avoiding the effects of cardiopulmonary bypass on cerebral hemodynamics and microembolic load, TAVI is assumed to be beneficial regarding… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Transcatheter aortic valve implantation.
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2009to Dec 2010
- Phase
- Observational
- 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
Study population: Patients with aortic stenosis rejected for open-heart surgery due to unacceptable risks.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Thoracic Anaesthesia & Intensive Care,Sahlgrenska University Hospital
Gothenburg, 41345
About this study
Official title: Transcranial Doppler Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation
Transcatheter Aortic Valve Implantation (TAVI) using femoral access is an option for definitive treatment of aortic stenosis when open-heart surgery is considered inappropriate. By avoiding the effects of cardiopulmonary bypass on cerebral hemodynamics and microembolic load, TAVI is assumed to be beneficial regarding risk for neurological complications. We anticipated that the extensive endovascular retrograde manipulation in ascending aorta and aortic root would generate a detectable cerebral microembolic load, and thus an increase in serological markers of neuronal injury postoperatively. Our hypothesis is that there is a positive correlation between the total amount of cerebral microembolic events during the TAVI procedure and the Area under curve (AUC24hrs) for the release pattern of two markers of neuronal injury. We also wish to describe the extent and distribution of microembolisms during the TAVI procedure using Transcranial Doppler (TCD).
Read the detailed description
Patients scheduled for TAVI at our institution are screened for inclusion into this prospective, observational study. A multidisciplinary expert committee evaluate all high-risk patients diagnosed with aortic stenosis. If rejected for open-heart surgery, and without contraindications for transcatheter approach, the patient is offered treatment with TAVI using the CoreValve ® (Medtronic, Inc., Minneapolis, Minnesota) system. The Human Ethics Committee of the University of Gothenburg, approved the study protocol, and all patients sign an informed, written consent. CoreValve ® is a TAVI system delivering a tri-leaflet bioprosthetic porcine pericardial tissue valve mounted and sutured in a self-expanding nitinol frame, using a trans-femoral or trans-subclavian artery access approach. Details regarding the TAVI procedure have been described previously . On the evening before surgery, the patients receive a loading dose of clopidogrel 300 mg. The morning of surgery an additional dose of clopidogrel 75 mg, together with acetylsalicylic acid 75 mg is given.
No sedative premedication is given before the procedure. On arrival at OR, standard perioperative monitoring is established, including an Auditory Evoked Potential (AEP) monitor for anaesthetic depth measurements (AEP Monitor/2, Danmeter, Odense, Denmark) and radial arterial and central venous lines. General anaesthesia is induced with propofol 0.5-1 mg/kg and fentanyl 100-150 μg. Tracheal intubation facilitated using atracurium 0,5 mg/kg. A propofol infusion is used to maintain an anaesthetic depth adjusted to an AAI index of 15-30 as recorded by the AEP monitor. Hemodynamic stability is obtained by the use of colloidal solution administration, guided by the use of intra-operative transesophageal echocardiography, and norephineprine to maintain a mean arterial pressure above 75 mmHg. During the procedure, intravenous heparin is administered to achieve an activated clotting time > 250 sec. Catheters and guide-wires are flushed and cleaned according to standard procedures at our laboratory. The preparation of the valve is performed according to the instructions of the manufacturer. The balloon valvuloplasty of the native aortic valve is performed under rapid right ventricular pacing (180 bpm) and the self-expandable prosthesis deployed stepwise without pacing. The same team of two interventional cardiologists and one cardiothoracic anaesthesiologist perform all procedures. A certified cardiologist or anaesthesiologist assess focal neurological impairment before and within 24 hours after the procedure.
- Conditions
- Aortic Stenosis
- Being tested
- Transcatheter aortic valve implantation.
- Keywords
- Embolism, Nervous system, Aorta, Valves, Ultrasonics
- Medical subject headings
- Aortic Valve Stenosis, Embolism, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve implantation.Device
Also called Core Valve ® (Medtronic, Inc., Minneapolis, Minnesota)
Transcatheter aortic valve implantation,femoral access.
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcranial Doppler microembolic signals during transcatheter aortic valve implantation
Measured: During surgery
Secondary outcomes (1)
Area under curve for the release pattern of serum S-100β after transcatheter aortic valve implantation
Measured: 24 Hour after Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startJul 2009
- Primary completionDec 2010
- Study completionDec 2010
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 Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sven Erik Ricksten, Professor, Study director, Sahlgrenska University Hospital,Thoracic Anesthesia & Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237743
- Sponsor's protocol ID
- Dnr304-09
- Status last verified
- Nov 2010
- First submitted
- 9 Nov 2010
- Last updated
- 15 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
PubMed 20961243Dittrich R, Ringelstein EB. Occurrence and clinical impact of microembolic signals during or after cardiosurgical procedures. Stroke. 2008 Feb;39(2):503-11. doi: 10.1161/STROKEAHA.107.491241. Epub 2008 Jan 3.
PubMed 18174490Lund C, Nes RB, Ugelstad TP, Due-Tonnessen P, Andersen R, Hol PK, Brucher R, Russell D. Cerebral emboli during left heart catheterization may cause acute brain injury. Eur Heart J. 2005 Jul;26(13):1269-75. doi: 10.1093/eurheartj/ehi148. Epub 2005 Feb 16.
PubMed 15716287Webb JG, Pasupati S, Humphries K, Thompson C, Altwegg L, Moss R, Sinhal A, Carere RG, Munt B, Ricci D, Ye J, Cheung A, Lichtenstein SV. Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis. Circulation. 2007 Aug 14;116(7):755-63. doi: 10.1161/CIRCULATIONAHA.107.698258. Epub 2007 Jul 23.
PubMed 17646579Reinsfelt B, Westerlind A, Ioanes D, Zetterberg H, Freden-Lindqvist J, Ricksten SE. Transcranial Doppler microembolic signals and serum marker evidence of brain injury during transcatheter aortic valve implantation. Acta Anaesthesiol Scand. 2012 Feb;56(2):240-7. doi: 10.1111/j.1399-6576.2011.02563.x. Epub 2011 Oct 19.
PubMed 22092012
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Doppler Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT01237743
- Acronym / sponsor ID
- Dnr304-09
- Conditions
- Aortic Stenosis
- Keywords
- Embolism, Nervous system, Aorta, Valves, Ultrasonics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Nov 2010 (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.
Transcatheter Aortic Valve Implantation (TAVI) using femoral access is an option for definitive treatment of aortic stenosis when open-heart surgery is considered inappropriate. By avoiding the effects of cardiopulmonary bypass on cerebral hemodynamics and microembolic load, TAVI is assumed to be beneficial regarding risk for neurological complications. We anticipated that the extensive endovascular retrograde manipulation in ascending aorta and aortic root would generate a detectable cerebral microembolic load, and thus an increase in serological markers of neuronal injury postoperatively. Our hypothesis is that there is a positive correlation between the total amount of cerebral microembolic events during the TAVI procedure and the Area under curve (AUC24hrs) for the release pattern of two markers of neuronal injury. We also wish to describe the extent and distribution of microembolisms during the TAVI procedure using Transcranial Doppler (TCD).
Detailed description
Patients scheduled for TAVI at our institution are screened for inclusion into this prospective, observational study. A multidisciplinary expert committee evaluate all high-risk patients diagnosed with aortic stenosis. If rejected for open-heart surgery, and without contraindications for transcatheter approach, the patient is offered treatment with TAVI using the CoreValve ® (Medtronic, Inc., Minneapolis, Minnesota) system. The Human Ethics Committee of the University of Gothenburg, approved the study protocol, and all patients sign an informed, written consent. CoreValve ® is a TAVI system delivering a tri-leaflet bioprosthetic porcine pericardial tissue valve mounted and sutured in a self-expanding nitinol frame, using a trans-femoral or trans-subclavian artery access approach. Details regarding the TAVI procedure have been described previously . On the evening before surgery, the patients receive a loading dose of clopidogrel 300 mg. The morning of surgery an additional dose of clopidogrel 75 mg, together with acetylsalicylic acid 75 mg is given.
No sedative premedication is given before the procedure. On arrival at OR, standard perioperative monitoring is established, including an Auditory Evoked Potential (AEP) monitor for anaesthetic depth measurements (AEP Monitor/2, Danmeter, Odense, Denmark) and radial arterial and central venous lines. General anaesthesia is induced with propofol 0.5-1 mg/kg and fentanyl 100-150 μg. Tracheal intubation facilitated using atracurium 0,5 mg/kg. A propofol infusion is used to maintain an anaesthetic depth adjusted to an AAI index of 15-30 as recorded by the AEP monitor. Hemodynamic stability is obtained by the use of colloidal solution administration, guided by the use of intra-operative transesophageal echocardiography, and norephineprine to maintain a mean arterial pressure above 75 mmHg. During the procedure, intravenous heparin is administered to achieve an activated clotting time > 250 sec. Catheters and guide-wires are flushed and cleaned according to standard procedures at our laboratory. The preparation of the valve is performed according to the instructions of the manufacturer. The balloon valvuloplasty of the native aortic valve is performed under rapid right ventricular pacing (180 bpm) and the self-expandable prosthesis deployed stepwise without pacing. The same team of two interventional cardiologists and one cardiothoracic anaesthesiologist perform all procedures. A certified cardiologist or anaesthesiologist assess focal neurological impairment before and within 24 hours after the procedure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with aortic stenosis rejected for open-heart surgery due to unacceptable risks.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Transcatheter aortic valve implantation.Also: Core Valve ® (Medtronic, Inc., Minneapolis, Minnesota)Transcatheter aortic valve implantation,femoral access. | Device | – |
Primary outcome
Transcranial Doppler microembolic signals during transcatheter aortic valve implantation
Time frame: During surgery
1 secondary outcome
Area under curve for the release pattern of serum S-100β after transcatheter aortic valve implantation
Time frame: 24 Hour after Surgery
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 15 Mar 2011.
- Background: PubMed 20961243Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
- Background: PubMed 18174490Dittrich R, Ringelstein EB. Occurrence and clinical impact of microembolic signals during or after cardiosurgical procedures. Stroke. 2008 Feb;39(2):503-11. doi: 10.1161/STROKEAHA.107.491241. Epub 2008 Jan 3.
- Background: PubMed 15716287Lund C, Nes RB, Ugelstad TP, Due-Tonnessen P, Andersen R, Hol PK, Brucher R, Russell D. Cerebral emboli during left heart catheterization may cause acute brain injury. Eur Heart J. 2005 Jul;26(13):1269-75. doi: 10.1093/eurheartj/ehi148. Epub 2005 Feb 16.
- Background: PubMed 17646579Webb JG, Pasupati S, Humphries K, Thompson C, Altwegg L, Moss R, Sinhal A, Carere RG, Munt B, Ricci D, Ye J, Cheung A, Lichtenstein SV. Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis. Circulation. 2007 Aug 14;116(7):755-63. doi: 10.1161/CIRCULATIONAHA.107.698258. Epub 2007 Jul 23.
- Derived from this study: PubMed 22092012Reinsfelt B, Westerlind A, Ioanes D, Zetterberg H, Freden-Lindqvist J, Ricksten SE. Transcranial Doppler microembolic signals and serum marker evidence of brain injury during transcatheter aortic valve implantation. Acta Anaesthesiol Scand. 2012 Feb;56(2):240-7. doi: 10.1111/j.1399-6576.2011.02563.x. Epub 2011 Oct 19.
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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.
Sven Erik Ricksten, Professor study director
Sahlgrenska University Hospital,Thoracic Anesthesia & Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 0 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 15 Mar 2011. 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 Sweden. 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?
Transcranial Doppler microembolic signals during transcatheter aortic valve implantation (time frame: During surgery). 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 NCT01237743, 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 15 Mar 2011.