Anticoagulation for Aortic Bioprosthesis (ANTIPRO)
Aortic Valve StenosisAortic Valve Disease2 moreThis study evaluates the clinical and hemodynamic outcome in patients after aortic valve replacement. Half of the patients will receive warfarin + aspirin and the other half will receive only aspirin. The investigators will focus mainly on early bioprosthesis degeneration.
Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis
Aortic StenosisTo assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with low-gradient, severe aortic stenosis. To assess the impact of aortic valve replacement as compared to medical therapy on clinical outcome of patients with low-gradient, severe aortic stenosis. To assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities on the assessment of AS severity and definition of low gradient severe aortic stenosis.
The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of...
HyperglycemiaAortic Valve Replacement2 moreThe overall research plan is to test the hypothesis that intraoperative treatment of hyperinsulinemic normoglycemic clamp (HNC) in cardiac surgical patients improves myocardial function and short-term outcomes compared with standard glucose management.
Analgesia in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation (TF-TAVI)...
Aortic Valve StenosisIlioinguinal and iliohypogastric (ILIH) nerve blocks are frequently performed for analgesia in inguinal surgery. The investigators hypothesized that preoperative ultrasound-guided ilioinguinal and iliohypogastric (ILIH) nerve blocks will produce better intraoperative analgesia and less analgesic requirement postoperatively in comparison to commonly used preoperative local infiltration anaesthesia for patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI).
SAPIEN 3 Ultra System PMCF
Aortic Valve StenosisA post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
SAPIEN 3 Ultra EU PMS
Aortic StenosisAortic Valve StenosisThis study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating early discharge home.
Cardiac Function After Minimally Invasive Aortic Valve Implantation
Aortic Valve StenosisHeart Valve DiseasesThis is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible. Forty patients will be randomly assigned to either minimally invasive (20 patients) or conventional AVR (20 patients). CE-marked and FDA-approved mechanical and bioprosthetic aortic valves (conventional stented or sutureless bioprostheses) will be implanted. Transthoracic echocardiography will be performed before surgery, and at day 1, 4, and 40. Echocardiographic parameters as well as preoperative clinical characteristics and postoperative clinical outcomes will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement
Aortic Valve StenosisHeart Valve DiseasesThis is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible. One-hundred patients will be randomly assigned to either partial upper sternotomy (50 patients) or full sternotomy AVR (50 patients). Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement. Exclusion criteria are inclusion in other trial, left ventricular ejection fraction less than 0.45, previous cardiac surgery, or urgent/emergent surgery. Mechanical and bioprosthetic (stented or sutureless) aortic valves will be implanted. Clinical characteristics will be registered. Clinical postoperative outcomes including bleeding outcomes will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the...
Aortic StenosisThe purpose of this study is to evaluate whether treatment with an investigational drug as compared to placebo will reduce the risk of major cardiovascular events in patients with aortic stenosis.
Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis
Aortic StenosisTranscatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk elderly with aortic stenosis, however, mortality remains high. Fifty percent of patients undergoing TAVR exhibit frailty, a syndrome associated with poor survival. It is unknown whether interventions to improve frailty before TAVR (prehabilitation) will improve outcomes after TAVR. This study plans to evaluate whether simple cardiac exercise interventions to improve physical performance before TAVR improves outcomes after TAVR.