Cardiovascular Surgery

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. BoxX-NoAF Clinical Trial

   Rochester, Minn.

   Post Operative Atrial Fibrillation (POAF) is the most common complication of cardiac surgery. POAF incidence can exceed 50% depending on the patient baseline characteristics and surgery type. Patients with POAF tend to have worse acute and long-term clinical outcomes. BoxX-NoAF is a randomized trial to evaluate if prophylactic ablation and exclusion of the Left Atrial Appendage at the time of other routine cardiac surgery can reduce the incidence of post operative AF and clinical AF during long term follow up in patients who have not yet developed AF but are at risk.

2. STAR Trial (Siegel Transcatheter Aortic Valve Replacement In Patients With Symptomatic Severe Aortic Stenosis)

   Jacksonville, Fla., Rochester, Minn.

   To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.

3. A Study to Evaluate Noninvasive Ultrasound Elastography of Kidney and Lung in Assessment of Volume Status in ICU Patients

   Rochester, Minn.

   The primary purpose of this study is to assess the feasibility of performing lung and kidney and lung ultrasound elastography among patients with critical illness from different etiologies that could be associated with volume overload.

4. A Study To Evaluate Endovascular Ablation Of The Right Greater Splanchnic Nerve In Subjects Having Heart Failure With Preserved Ejection Fraction

   Rochester, Minn.

   The objective of this clinical evaluation is to assess the safety and initial effectiveness of catheter-based unilateral ablation of the right greater splanchnic nerve (GSN) in subjects having heart failure with preserved ejection fraction (HFpEF).

5. Treatment In Thoracic Aortic Aneurysm: Surgery Vs Surveillance

   Rochester, Minn.

   The ascending aorta conducts blood from the heart to the rest of the body. The ascending aorta can become enlarged, and the risk of tearing and rupturing becomes higher with larger aorta. When the ascending aorta tears or ruptures, the risk dying is high even if surgery is done as soon as possible. Traditionally, when the ascending aorta gets above 5.5 cm, surgery is recommended to replace the aorta. However, this threshold is based relatively weak evidence, and sometimes patients with smaller aorta can tear or rupture. On the other hand, surgery carries its own risk as well. Since there are risk of waiting or doing surgery, there is currently no great support for either approach for patients with a smaller aorta. In the TITAN SvS trial, patients with an ascending aorta between 5.0 to 5.5 cm is assigned by chance to the early surgery group, in which they will undergo replacement of aorta, or the surveillance group, in which they will be closely monitored. The chance of dying or suffer tearing or rupture of aorta between the two groups will be compared. The result of the trial will guide future practice for patients with enlarged ascending aorta.
   
   This is a prospective, multi-centre randomized control trial that compares the all-cause mortality, aneurysm-related aortic events, rate of stroke, and quality of life for those patients undergoing early elective ascending aortic surgery to those patients undergoing surveillance. Patients referred for an ascending aortic aneurysm that meets the inclusion criteria will be randomized to the early elective surgery group or the surveillance group. Recruitment will end when the desired sample size is reached, and the patients will be followed for a minimum 2-year period. The primary objective of the trial is to compare the composite outcome of the all-cause mortality and incidence of acute aortic events between surveillance and elective ascending aortic surgery for patients with degenerative or bicuspid valve-related ascending aortic aneurysm after 2 years of follow up. The hypothesis is that the early surgery group will have a significantly lower all-cause mortality and incidence of acute aortic events at 2 years of follow up compare to the surveillance group. The result of this trial will provide evidence based guidance in the appropriate management of ascending aortic aneurysm based on the size criteria, and establish a large database for future investigations.

6. Multimodality Evaluation of Left Ventricular Remodeling

   Rochester, Minn.

   The purpose of this study is to use a multimodal approach to mitral valve evaluation using cardiac CT and MRI, which have shown superior accuracy in assessing anatomic and functional parameters relative to standard-of-care echocardiography. By evaluating 30 patients undergoing robotic mitral annuloplasty, this study aims to establish the feasibility of further prospective evaluation of CT and MRI for preoperative risk stratification. Enhanced risk stratification could significantly improve patient outcomes.

    

7. A Study to Evaluate ICU Simulation Experience in the Cardiothoracic Surgical Population to Reduce Post-operative Delirium

   Rochester, Minn.

   The purpose of this study is to evaluate the effect of a pre-ICU admission simulation session on post-operative delirium in the elective cardiothoracic surgical population while in the intensive care unit.