Aortic Stenosis Clinical Trial
Official title:
Reducing Delirium After Trans-Apical Aortic Valve Replacement (TAVI): A Multifaceted Approach of Perioperative Care
Trans-apical aortic valve replacement is a new treatment for severe aortic stenosis. It is
offered to elderly patients with medical problems that would markedly increase the risk of
conventional cardiac surgery. The rate of delirium (acute confusional state) after surgery in
these patients may exceed 50%. Estimated hospital costs associated with delirium at Toronto
General Hospital last year exceeded $1-million CAD. Pain after surgery and the use of opioids
(morphine type of pain-relief drugs) are known to increase the risk of delirium. The
investigators plan to minimize the use of opioids and improve pain management by replacing
the standard intravenous opioid-based pain management with the paravertebral nerve block
using only the local anesthetic. These two management strategies will be compared with
respect to the rate of delirium, duration of hospital stay, and the overall costs.
Hypothesis: Paravertebral analgesia with LA decreases the incidence of delirium after
trans-apical AVR when compared to standard systemic opioid-based analgesia.
A prospective, randomized, controlled, multicentre study (Toronto General Hospital and
Sunnybrook Health Science Centre, Toronto, Canada.) The investigators are planning to replace
the standard intravenous opioid analgesia with a continuous paravertebral block using local
anesthetic after trans-apical aortic valve replacement.
Anesthesia management will be standardized to minimize any impact that anesthetic type may
have on neurological outcomes.
Metrics to evaluate outcomes: Assessment of delirium will be performed utilizing the CAM-ICU
preoperatively (baseline) and postoperatively every 12 hours or as needed according to the
patient's condition during the first 7 postoperative days or until discharge.
The CAM recognizes both, hyperactive and hypoactive, forms of delirium. It includes four-step
algorithm and assesses 1) an acute onset of changes or fluctuations in the course of mental
status, 2) inattention, 3) disorganized thinking and 4) an altered level of consciousness.
The patient is determined to be delirious (CAM positive) if he/she manifests both features 1
and 2, plus either feature 3 or 4.
Primary screening for delirium will be performed by the nursing staff. Diagnose of delirium
will be confirmed by the psychiatry consult. Assessment of Sedation and Pain: Standardized
according to institutional guidelines.
Cost Calculations: The total cost (summation of direct-variable, direct-fixed, and overhead
costs) for each patient will be determined for both study groups.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04310046 -
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
|
N/A | |
Completed |
NCT03332745 -
Mechanism of Decompensation Evaluation - Aortic Stenosis
|
||
Recruiting |
NCT06008080 -
Post-Market Clinical Follow Up Study With Navitor Valve
|
||
Recruiting |
NCT06055751 -
Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
|
||
Active, not recruiting |
NCT04815785 -
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
|
N/A | |
Terminated |
NCT02202434 -
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
|
N/A | |
Recruiting |
NCT03029026 -
The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
|
||
Active, not recruiting |
NCT02903420 -
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
|
N/A | |
Completed |
NCT02629328 -
CardioCel Tri-leaflet Repair Study
|
N/A | |
Completed |
NCT02306226 -
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
|
||
Completed |
NCT01676727 -
ADVANCE Direct Aortic Study
|
||
Withdrawn |
NCT01648309 -
Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation
|
N/A | |
Completed |
NCT01422044 -
Risk Prediction in Aortic Stenosis
|
N/A | |
Withdrawn |
NCT00774657 -
Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography
|
N/A | |
Terminated |
NCT00535899 -
Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS)
|
N/A | |
Terminated |
NCT05070130 -
OpSens PRIME CLASS
|
||
Completed |
NCT03314857 -
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
|
N/A | |
Completed |
NCT04157920 -
Impact of Predilatation Between Self-expanding Valves
|
N/A | |
Enrolling by invitation |
NCT06212050 -
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
|
||
Recruiting |
NCT05893082 -
Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
|
N/A |