- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01237743
Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation.
Transcranial Doppler Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gothenburg, Sweden, 41345
- Department of Thoracic Anaesthesia & Intensive Care,Sahlgrenska University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria: Clinical diagnosis of Aortic stenosis rejected for open-heart surgery.
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Exclusion Criteria: None
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Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Transcranial Doppler microembolic signals during transcatheter aortic valve implantation
Time Frame: During surgery
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During surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Area under curve for the release pattern of serum S-100β after transcatheter aortic valve implantation
Time Frame: 24 Hour after Surgery
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24 Hour after Surgery
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Collaborators and Investigators
Investigators
- Study Director: Sven Erik Ricksten, Professor, Sahlgrenska University Hospital,Thoracic Anesthesia & Intensive Care
Publications and helpful links
General 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.
- Webb 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.
- Dittrich 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.
- Lund 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.
- Reinsfelt 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr304-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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