Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation.

This study has been completed.
Sponsor:
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01237743
First received: November 9, 2010
Last updated: March 14, 2011
Last verified: November 2010
  Purpose

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).


Condition Intervention
Aortic Stenosis
Device: Transcatheter aortic valve implantation.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Transcranial Doppler Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Transcranial Doppler microembolic signals during transcatheter aortic valve implantation [ Time Frame: During surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area under curve for the release pattern of serum S-100β after transcatheter aortic valve implantation [ Time Frame: 24 Hour after Surgery ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Serum levels of S-100β Determined by an electrochemoluminescence immunoassay using the Modular system and the S100β reagent kit (Roche Diagnostics, Basel, Switzerland).


Enrollment: 21
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Transcatheter aortic valve implantation.
    Transcatheter aortic valve implantation,femoral access.
    Other Name: Core Valve ® (Medtronic, Inc., Minneapolis, Minnesota)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with aortic stenosis rejected for open-heart surgery due to unacceptable risks.

Criteria

Inclusion Criteria: Clinical diagnosis of Aortic stenosis rejected for open-heart surgery.

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Exclusion Criteria: None

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01237743

Locations
Sweden
Department of Thoracic Anaesthesia & Intensive Care,Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Study Director: Sven Erik Ricksten, Professor Sahlgrenska University Hospital,Thoracic Anesthesia & Intensive Care
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Sven Erik Ricksten, Sahlgrenska University Hospital. The sahlgrenska Academy.Institution Of Thoracic Anaesthesia & Intensive Care,Gothenburg Sweden
ClinicalTrials.gov Identifier: NCT01237743     History of Changes
Other Study ID Numbers: Dnr304-09
Study First Received: November 9, 2010
Last Updated: March 14, 2011
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Sahlgrenska University Hospital, Sweden:
Embolism
Nervous system
Aorta
Valves
Ultrasonics

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 18, 2014